Randomized trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy in PAH group I patients – TripleTRE

2023-504351-26-01 Protocol TREV1-10P.401 Phase III and Phase IV (Integrated) Ongoing, recruiting

Start 6 Dec 2023 · Status Ongoing, recruiting · 12 EU/EEA countries · 28 sites · Protocol TREV1-10P.401

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ongoing, recruiting
Participants planned 133
Countries 12
Sites 28

Pulmonary arterial hypertension (group I)

Primary objective of the trial is to investigate the effect of initial triple combination therapy (oral ERA + oral PDE-5i + parenteral treprostinil) compared to initial double oral therapy (oral ERA + oral PDE-5i) on risk status in PAH patients (group I)

Key facts

Sponsor
Aop Orphan Pharmaceuticals GmbH
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
6 Dec 2023 → ongoing
Decision date (initial)
2023-10-02
Transition trial
No
Low-intervention
Yes
Rare-disease indication
Yes
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Primary objective of the trial is to investigate the effect of initial triple combination therapy (oral ERA + oral PDE-5i + parenteral treprostinil) compared to initial double oral therapy (oral ERA + oral PDE-5i) on risk status in PAH patients (group I)

Secondary objectives 1

  1. Secondary objective is to investigate the effect of initial triple therapy (oral ERA + oral PDE-5i + parenteral treprostinil) compared to initial double oral therapy (oral ERA + oral PDE-5i) on haemodynamics, exercise capacity, disease severity and quality of life in PAH patients (group I)

Conditions and MedDRA coding

Pulmonary arterial hypertension (group I)

VersionLevelCodeTermSystem organ class
21.1 PT 10064911 Pulmonary arterial hypertension 100000004855

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-504351-26-00 Randomized trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy in PAH group I patients – TripleTRE Aop Orphan Pharmaceuticals GmbH

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Signed informed consent prior to any trial-mandated procedure
  2. Male or female ≥ 18 and ≤ 70 years of age
  3. Symptomatic treatment-naïve PAH patients (group I) with confirmed diagnosis of one of the following subgroups: IPAH, HPAH, Drug and toxin-induced PAH, PAH associated with Connective Tissue Disease, PAH with corrected congenital heart disease
  4. Intermediate-high risk patients rated according to the simplified four-strata risk-assessment tool or intermediate-low risk with severe haemodynamic impairment as defined in current PH guidelines i.e., mean right atrial pressure (RAP) ≥ 20 mmHg, cardiac index (CI) < 2.0 L/min, stroke volume index (SVI) < 31 mL/ and/or pulmonary vascular resistance (PVR) ≥ 12 WU
  5. Right Heart Catheterization (RHC) meeting all the following criteria: Mean pulmonary arterial pressure (mPAP) > 20 mmHg, Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, PVR > 2 Wood Units
  6. Women of childbearing potential must not be pregnant or lactating, must perform regular pregnancy tests, if sexually active, agree to continue to use reliable method(s) of contraception until study completion

Exclusion criteria 26

  1. PAH patients (group I) belonging to one of the following subgroups: Schistosomiasis, HIV infection, Portal hypertension, Diffuse systemic sclerosis, Uncorrected congenital heart disease including uncorrected systemic-to-pulmonary shunts
  2. Any PAH-specific drug therapy in the past 3 months
  3. Patients responding to vasoreactivity testing with calcium channel blockers (CCB)
  4. Post-capillary PH and left heart disease
  5. Known or suspected pulmonary veno-occlusive disease (PVOD)
  6. Any PH due to lung disease
  7. Any disorder of the respiratory system expressed by DLCO <40% and a noticeable imaging result (e.g., CT) and TLC <60% and FEV1 <70% by plethysmography (a pulmonary function test)
  8. Patients with need of ambulatory or long-term oxygen therapy
  9. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 480 msec at randomization
  10. Body mass index (BMI) > 35 (kg/m2)
  11. Age > 70 years
  12. History of restrictive, constrictive or congestive cardiomyopathy, atrial septostomy, any symptomatic coronary disease events within 6 months, severe uncontrolled arterial hypertension, acutely decompensated heart failure and myocardial infarction within 30 days, significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease, chronic systemic hypotension, unstable angina pectoris, permanent/persistent atrial fibrillation and/or need for pacemaker
  13. Patients with acute anaemia with haemoglobin (Hb) values <11 g/dL
  14. Cerebrovascular accident within 3 months
  15. Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3× upper limit of the normal range (ULN) accompanied by aspartate aminotransferase (AST) > ULN and/or Child-Pugh Class C
  16. Documented renal insufficiency with GFR <30 ml/min
  17. Patients with untreated sleep apnoea
  18. Patient with other cardiovascular, liver, renal, haematologic, gastrointestinal (including active gastrointestinal ulcer), immunologic, endocrine (e.g., uncontrolled diabetes), metabolic, or central nervous system disease and acute bleeding and injuries (e.g., intracranial haemorrhage) that, in the opinion of the investigator, may adversely affect the safety of the patient and /or efficacy of the therapy or significantly limit the lifespan (< 12 months)
  19. Patients with major surgery in the last 12 months
  20. Known history of alcohol abuse
  21. Treatment of a CYP2C8 enzyme inducer (e.g., rifampicin) ≤ 28 days and/or treatment of a cytochrome P450 (CYP)2C8 enzyme inhibitor (e.g., gemfibrozil) ≤ 28 days
  22. Treatment with another investigational drug (planned, or taken ≤ 12 weeks)
  23. Hypersensitivity to any of the trial treatments or any excipient of their formulations
  24. Pregnancy, breastfeeding, or intention to become pregnant during the trial
  25. Any other significant disease or disorder which, in the opinion of the investigator, may put the patients at risk when participating in the trial
  26. Any factor or condition likely to affect protocol compliance of the patient, as judged by the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. (Non-) Response to the assigned treatment: 1. Therapy-responder: achievement of low-risk status between week 24 and week 48 2. Therapy-non-responder: a) PH related deterioration to high-risk status, lung transplantation or death between week 12 and week 48 and/or b) additional medication or change of initial PH specific medication due to unsatisfactory efficacy between week 12 and week 48 and/or c) low risk status not achieved up to week 48 Risk status is assessed with the simplified four-

Secondary endpoints 15

  1. Change in haemodynamic parameters by means of right heart catheterization (RHC) between baseline and week 24: a. Pulmonary Vascular Resistance (PVR) b. Mean pulmonary arterial pressure (mPAP) c. Mean right atrial pressure (mRAP) d. Right atrial pressure (RAP) e. Cardiac index (CI) f. Cardiac output (CO)
  2. Change in right heart structure and function assessed by echocardiography between baseline and week 24: a. RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure (TAPSE/sPAP) b. RV end-diastolic area (RVEDA) c. RV end-systolic area (RVESA) d. RV fractional area change (RVFAC) e. Right atrium (RA) area f. Pericardial effusion
  3. Time to achievement of low-risk status assessed by the simplified four-strata risk-assessment tool
  4. Rate of change of risk status by means of the simplified four-strata risk-assessment tool
  5. Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool between baseline and week 24
  6. Change in REVEAL 2.0 risk score between baseline and week 24
  7. Rate of change in WHO FC
  8. Rate of change in 6MWD
  9. Rate of change in NT-proBNP/BNP levels
  10. Change in quality of life by questionnaires emPHasis-10 and EQ-5D-5L
  11. Total number of clinical worsening(s) where clinical worsening is defined as: PAH related death (including all deaths where PAH cannot be excluded as cause) and lung transplantation due to PAH, PH-related hospitalization, Post baseline (screening visit) decrease in 6MWD by 15%, Post baseline (screening visit) worsening of WHO FC
  12. Overall and transplant free survival
  13. Adverse events (AE), Adverse reactions (ADR)
  14. Serious Adverse events (SAE), Serious Adverse Drug Reactions (SADR)
  15. Suspected unexpected serious adverse reactions (SUSAR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 16

Trisuva 5 mg/ml Infusionslösung

PRD8263821 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
138381
MA holder
AOP ORPHAN PHARMACEUTICALS GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 5 mg/ml soluzione per infusione

PRD9211247 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
049207032
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 1 mg/ml soluzione per infusione

PRD9211051 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
049207018
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 10 mg/ml Infusionslösung

PRD9011542 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
2205033.00.00
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 5 mg/ml Infusionslösung

PRD9011523 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
2205032.00.00
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TREPOSUVI 5 mg/ml, solution pour perfusion

PRD8852191 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
34009 302 205 5 9
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trisuva 2,5 mg/ml Infusionslösung

PRD8263812 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
138380
MA holder
AOP ORPHAN PHARMACEUTICALS GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trisuva 1 mg/ml Infusionslösung

PRD8263793 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
138383
MA holder
AOP ORPHAN PHARMACEUTICALS GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TREPOSUVI 10 mg/ml, solution pour perfusion

PRD8852192 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
34009 302 205 6 6
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 10 mg/ml soluzione per infusione

PRD9213508 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
049207044
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 2,5 mg/ml soluzione per infusione

PRD9211214 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
049207020
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 2,5 mg/ml Infusionslösung

PRD9011522 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
2205031.00.00
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trisuva 10 mg/ml Infusionslösung

PRD8263825 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Week(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
138382
MA holder
AOP ORPHAN PHARMACEUTICALS GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TREPOSUVI 1 mg/ml, solution pour perfusion

PRD8852190 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
34009 302 205 2 8
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresuvi 1 mg/ml Infusionslösung

PRD9011428 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
2205030.00.00
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TREPOSUVI 2,5 mg/ml, solution pour perfusion

PRD8852193 · Product

Active substance
Treprostinil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max total dose
0.01 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
720 Month(s)
Authorisation status
Authorised
ATC code
B01AC21 — -
Marketing authorisation
34009 302 205 3 5
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aop Orphan Pharmaceuticals GmbH

4 Total trials 2 Recruiting 1 Ended
Commercial
Sponsor organisation
Aop Orphan Pharmaceuticals GmbH
Address
Leopold-Ungar-Platz 2, Döbling Döbling
City
Vienna
Postcode
1190
Country
Austria

Scientific contact point

Organisation
Aop Orphan Pharmaceuticals GmbH
Contact name
CMD Project Manager

Public contact point

Organisation
Aop Orphan Pharmaceuticals GmbH
Contact name
CMD Project Manager

Locations

12 EU/EEA countries · 28 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 20 2
Czechia Ongoing, recruiting 15 2
France Ongoing, recruiting 20 2
Germany Ongoing, recruiting 15 5
Hungary Ongoing, recruiting 7 3
Italy Ongoing, recruiting 10 2
Netherlands Authorised, recruitment pending 10 1
Poland Ongoing, recruiting 10 3
Portugal Ongoing, recruiting 4 2
Romania Ongoing, recruiting 10 2
Slovakia Authorised, recruitment pending 6 2
Spain Ongoing, recruiting 6 2
Rest of world — 0 —

Investigational sites

Austria

2 sites · Ongoing, recruiting
Ordensklinikum Linz GmbH
Cardiology, Fadingerstrasse 1, 4020, Linz
Medical University Of Vienna
Department of Medicin II, Division of Cardiology, Waehringer Guertel 18-20, Alsergrund, Vienna

Czechia

2 sites · Ongoing, recruiting
Vseobecna Fakultni Nemocnice V Praze
Pulmonology, U Nemocnice 499/2, Nove Mesto, Prague
University Hospital Olomouc
Cardiology, Zdravotniku 248/7, 779 00, Olomouc

France

2 sites · Ongoing, recruiting
Assistance Publique Hopitaux De Paris
Service de Pneumologie-Réanimation Respiratoire, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Les Hopitaux Universitaires De Strasbourg
Service de Pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex

Germany

5 sites · Ongoing, recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Internal Medicine I - Department of Pneumology;, Fetscherstrasse 74, Johannstadt-Nord, Dresden
DRK Kliniken Berlin
Cardiology, Eg., Spandauer Damm 130, Berlin
University Medicine Greifswald
Zentrum für Innere Medizin B - Pneumologie/Infektiologie, Ferdinand Sauerbruch Strasse, 17475, Greifswald
Universitätsklinikum Hamburg-Eppendorf - Zentrum für Onkologie, Studienzentrale Pneumologie
Pneumology, Martinistraße 52, 20246, Hamburg
Thoraxklinik Heidelberg gGmbH
Centre for pulmonary hypertension, Roentgenstrasse 1, Rohrbach, Heidelberg

Hungary

3 sites · Ongoing, recruiting
Semmelweis University
Pulmonology, Tomo Utca 25-29, 1083, Budapest VIII
University Of Szeged
Cardiology, Tisza Lajos Korut 109, 6725, Szeged
Gottsegen National Cardiovascular Center
Cardiology, Kerulet, Haller Utca 29/IX., Budapest

Italy

2 sites · Ongoing, recruiting
Sapienza University Of Rome
Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Dei Colli
Centre for pulmonary hypertension, Via Leonardo Bianchi, 80131, Naples

Netherlands

1 site · Authorised, recruitment pending
Amsterdam UMC Stichting
Department of Pulmonary Medicine, De Boelelaan 1117, 1081 HV, Amsterdam

Poland

3 sites · Ongoing, recruiting
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Ul. Pradnicka 80, 31-202, Cracow
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Oddzial Kardiologiczny, Ul. Borowa 14/18, 05-400, Otwock
Uniwersytecki Szpital Kliniczny W Poznaniu
I Klinika Kardiologii, Ul. Dluga 1/2, 61-848, Poznan

Portugal

2 sites · Ongoing, recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
Department of Cardiology, Avenida Torrado Da Silva, 2805-267, Almada
Hospital De Santa Maria E.P.E.
Cardiology, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon

Romania

2 sites · Ongoing, recruiting
Spitalul Clinic Judetean De Urgenta Targu Mures
Pulmonology, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
Cardiovascular, Soseaua Fundeni 258, 022328, Bucharest

Slovakia

2 sites · Authorised, recruitment pending
National Institute of Cardiovascular (NIS) Diseases in Slovakia
Department of Heart Failure and Transplantation, Pod Krasnou horkou1, 83101, Bratislava
East Slovakia Cardiovascular Institute
1st Clinic of Cardiology, Cardiology Deparmtent, Ondavska 8, 04011, Kosice

Spain

2 sites · Ongoing, recruiting
Hospital Clinic De Barcelona
Pulmonology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Pulmonology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-12-06 2023-12-06
Czechia 2024-06-13 2024-12-18
France 2024-10-18 2024-12-18
Germany 2024-04-26 2024-04-26
Hungary 2024-08-11 2025-02-06
Italy 2024-01-11 2024-01-11
Poland 2024-09-12 2024-09-12
Portugal 2024-09-25 2025-05-28
Romania 2024-06-20 2024-11-27
Spain 2024-05-08 2024-05-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 256 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol - Extract (for publication) D4_Patient facing documents_Patient diary_external pump_PT_IV_track changes 3.0
Protocol (for publication) D1_Protocol synopsis_IT_2023 504351 26_tc 2.1
Protocol (for publication) D1_Protocol_2023 504351 26 00_clean_redacted 2.1
Protocol (for publication) D1_Protocol_2023 504351 26 00_tc_redacted 2.1
Protocol (for publication) D1_Protocol_2023-504351-26-00_redacted 1.1
Protocol (for publication) D4_Patient facing document_emPHasis-10_PL 2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_PL 1
Protocol (for publication) D4_Patient facing document_Patient card_ENG 1
Protocol (for publication) D4_Patient facing document_Patient card_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient card_PL 2
Protocol (for publication) D4_Patient facing document_Patient diary_external pump_PL 2
Protocol (for publication) D4_Patient facing document_Patient diary_implantable pump_PL 2
Protocol (for publication) D4_Patient facing document_Pregnancy Test Diary_PL 1
Protocol (for publication) D4_Patient facing document_Questionnaire_emPHasis-10_GER 2.0
Protocol (for publication) D4_Patient facing document_Questionnaire_EQ-5D-5L_GER 1
Protocol (for publication) D4_Patient facing documents_Effective EQ 5D 5L Paper Self Complete_CZ 1
Protocol (for publication) D4_Patient facing documents_emPHasis 10_CZ 1
Protocol (for publication) D4_Patient facing documents_EQ-5D-5L_RO 2
Protocol (for publication) D4_Patient facing documents_Patient card_CZ 2
Protocol (for publication) D4_Patient facing documents_Patient card_DE 2.0
Protocol (for publication) D4_Patient facing documents_Patient card_DE 1
Protocol (for publication) D4_Patient facing documents_patient card_ES 2
Protocol (for publication) D4_Patient facing documents_Patient card_FR 2.0
Protocol (for publication) D4_Patient facing documents_patient card_FR_tc 2.0
Protocol (for publication) D4_Patient facing documents_patient card_HU 2
Protocol (for publication) D4_Patient facing documents_patient card_IT_tc 2.0
Protocol (for publication) D4_Patient facing documents_Patient card_PT 2
Protocol (for publication) D4_Patient facing documents_Patient card_RO 2
Protocol (for publication) D4_Patient facing documents_Patient diary external pump IV_AT_DE 2.0
Protocol (for publication) D4_Patient facing documents_Patient diary external pump IV_AT_DE_tc 2.0
Protocol (for publication) D4_Patient facing documents_Patient diary external pump SC_AT_DE 2.0
Protocol (for publication) D4_Patient facing documents_Patient diary external pump SC_AT_DE_tc 2.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_CZ 2
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_DE 1
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_DE 1
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_ENG 1
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_FR 1
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_IT 1
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_PT 2
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_PT_IV_clean 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_PT_SC_clean 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_PT_SC_track changes 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pump_RO 2
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_ES 2
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_HU 2
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_IV_HU 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_IV_HU_tc 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_SC_HU 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_external pumps_SC_HU_tc 3.0
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_CZ 2
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_DE 1
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_DE 1
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_ENG 1
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_FR 1
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_IT 1
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_PT 2
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pump_RO 2
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pumps_ES 2
Protocol (for publication) D4_Patient facing documents_Patient diary_implantable pumps_HU 2
Protocol (for publication) D4_Patient facing documents_Pregnancy Diary_ES 2
Protocol (for publication) D4_Patient facing documents_Pregnancy Diary_HU 1
Protocol (for publication) D4_Patient facing documents_Pregnancy Test Diary_AT_DE 1.0
Protocol (for publication) D4_Patient facing documents_Pregnancy Test Diary_CZ 1
Protocol (for publication) D4_Patient facing documents_Pregnancy Test Diary_FR 1.0
Protocol (for publication) D4_Patient facing documents_Pregnancy Test Diary_IT 1.0
Protocol (for publication) D4_Patient facing documents_Pregnancy Test Diary_PT 1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_DE V2.0
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_ENG 2.0
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_ES 2
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_FR 2.0
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_HU 2
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPHasis-10_IT 1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EmPhasis-10_PT 2
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_DE 1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_ENG 1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_ES 1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_FR 1.2
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_HU 1.3
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_IT 1.1
Protocol (for publication) D4_Patient facing documents_Questionnaire_EQ-5D-5L_PT 1.4
Protocol (for publication) D4_Patient facing documentsl_Pregnancy Test Diary_RO 1
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_CZ 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_CZ_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_ES 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_ES_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_FR 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_FR_tc 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_IT 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_IT_tc 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_PL 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_PL_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_RO 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump IV_RO_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_CZ 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_CZ_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_ES 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_ES_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_FR 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_FR_tc 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_IT 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_IT_tc 2.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_PL 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_PL_tc 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_RO 3.0
Protocol (for publication) D4_Patient facing materials_Patient diary_external pump SC_RO_tc 3.0
Protocol (for publication) D4_Patient facing_Questionnaire_emPHasis-10_RO 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_additionnel_FR_redacted 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_FR 1
Recruitment arrangements (for publication) K1_Recruitment Arrangement_NL 1.2
Recruitment arrangements (for publication) K1_Recruitment Arrangement_NL_tc 1.2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements for Poland_POL_V2_20240516_clean_Update 1.2
Recruitment arrangements (for publication) K1_Recruitment arrangements_CZ_ENG 3
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_SK 1.1
Recruitment arrangements (for publication) N1_Site suitability form_Hospital Clinic Barcelona_Investigator_redacted 1
Recruitment arrangements (for publication) N1_Suitability of facility form_Fundeni Bucharest_RO_redacted 1
Recruitment arrangements (for publication) N1_Suitability of facility form_Targu Mures_RO_redacted 1
Subject information and informed consent form (for publication) D4_Patient facing documents_emPHasis10_SK 1
Subject information and informed consent form (for publication) D4_Patient facing documents_EQ-5D-5L_SK 1.1
Subject information and informed consent form (for publication) D4_Patient facing documents_patient card_SK 1
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pump_IV_SK 1
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pump_SC_SK 1
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pumps_IV_HU 3.0
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pumps_IV_HU_tc 3.0
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pumps_SC_HU 3.0
Subject information and informed consent form (for publication) D4_Patient facing documents_Patient diary_external pumps_SC_HU_tc 3.0
Subject information and informed consent form (for publication) D4_Patient facing documents_Pregnancy Test Diary_SK 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_adults_DE 2.1
Subject information and informed consent form (for publication) L1_ SIS and ICF_adults_DE_track changes 2.1
Subject information and informed consent form (for publication) L1_ SIS and ICF_adults_FR 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_adults_IT 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Hungary 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Spain 2.0
Subject information and informed consent form (for publication) L1_ICF_CZ_for_Czech Rep 2.0
Subject information and informed consent form (for publication) L1_ICF_Informed Consent Form_PT 2.1
Subject information and informed consent form (for publication) L1_ICF_Romania 2.0
Subject information and informed consent form (for publication) L1_Informed Consent GDPR_CZ 1
Subject information and informed consent form (for publication) L1_Pregnancy ICF adults 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF_AT pregnancy_tc 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_CZ Main_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_CZ pregnancy 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_CZ pregnancy_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Data Protection_SK 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_DE pregnancy 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ES Main_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ES pregnancy 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR pregnancy 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_HU Main_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_HU pregnancy 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_IT Main_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_IT pregnancy 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_main_FR 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_main_PT_EN backtranslation 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_main_SK 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_main_SK_tc 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_NL Main 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_NL Main_tc 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_NL pregnant subject 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_NL pregnant subject_tc 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_PL 4.2
Subject information and informed consent form (for publication) L1_SIS and ICF_PL Main_tc 4.2
Subject information and informed consent form (for publication) L1_SIS and ICF_PL pregnancy_tc 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Subject and Partner_PL 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_pregnant_SK 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_pregnant_SK_tc 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_PT Main_tc 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_PT pregnancy 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_PT pregnancy_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_RO Main_tc 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_RO pregnancy 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_GP Letter_FR 1
Subject information and informed consent form (for publication) L2_ Other subject information_privacy consent_adults_IT 1
Subject information and informed consent form (for publication) L2_Patient Leaflet Spain_ES 02
Subject information and informed consent form (for publication) L2_Patient Leaflet Spain_ES_TC 02
Subject information and informed consent form (for publication) L3_Patient Leaflet Italy_IT 01 IT
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC__CZ_PIL_Tresuvi 1-10mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_AT_treprostinil sodium 10mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_AT_treprostinil sodium 1mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_AT_treprostinil sodium 2 5mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_AT_treprostinil sodium 5mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_CZ_Tresuvi_10mg_ml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_CZ_Tresuvi_1mg_ml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_CZ_Tresuvi_2 5mg_ml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_CZ_Tresuvi_5mg_ml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_DE_Tresuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_DE_Tresuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_DE_Tresuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_DE_Tresuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_ES_Tresuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_ES_Tresuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_ES_Tresuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_ES_Tresuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_FR_Treprosuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_FR_Treprosuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_FR_Treprosuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_FR_Treprosuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_HU_Tresuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_HU_Tresuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_HU_Tresuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_HU_Tresuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_IT_Tresuvi 1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_IT_Tresuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_IT_Tresuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_IT_Tresuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_AT_treprostinil sodium 1-10mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_DE_Tresuvi_1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_ES_Tresuvi_1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_FR_Treprosuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_FR_Treprosuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_FR_Treprosuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_FR_Treprosuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_HU_Tresuvi_1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_IT_Tresuvi 1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_PL_Tresuvi 1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_PT_Tresuvi_1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_RO_Tresuvi 1-10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PIL_treprostinil sodium 1-10mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PL_Tresuvi_1 mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PL_Tresuvi_10 mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PL_Tresuvi_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PL_Tresuvi_5 mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PT_Tresuvi_10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PT_Tresuvi_1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PT_Tresuvi_2 5 mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_PT_Tresuvi_5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_RO_Tresuvi 10mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_RO_Tresuvi 1mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_RO_Tresuvi 2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_RO_Tresuvi 5mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_treprostinil sodium 10mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_treprostinil sodium 1mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_treprostinil sodium 2 5mgml 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_treprostinil sodium 5mgml 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_DE_2023 504351 26_tc 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2023-504351-26 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DE 2023-504351-26-00 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DE_2023 504351 26 00 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2023-504351-26-00 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG_2023 504351 26 00 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG_2023 504351 26_tc 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2023-504351-26 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2023 504351 26 00 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2023 504351 26_tc 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_HU_2023 504351-26 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2023 504351 26 00 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2023-504351-26 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT_2023 504351 26_tc 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT_2023_504351-26 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_RO_2023 504351 26_tc 2.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_RO_2023-504351-26 2.1

Application history

21 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-02 Austria Acceptable
2023-09-25
 2023-09-28
2 NON SUBSTANTIAL MODIFICATION NSM-8 2023-10-06 Acceptable
2023-09-25
 2023-10-06
3 NON SUBSTANTIAL MODIFICATION NSM-10 2023-11-03 Austria Acceptable
2023-09-25
 2023-11-03
4 SUBSEQUENT ADDITION OF MSC APP-4 2023-11-21 Acceptable
2023-09-25
 2024-02-29
5 SUBSEQUENT ADDITION OF MSC APP-5 2023-11-21 2024-02-28
6 SUBSEQUENT ADDITION OF MSC APP-6 2023-11-21 Acceptable
2023-09-25
 2024-03-04
7 SUBSEQUENT ADDITION OF MSC APP-7 2023-11-21 Acceptable
2023-09-25
 2024-03-04
8 SUBSEQUENT ADDITION OF MSC APP-8 2023-11-21 Acceptable
2023-09-25
 2024-03-01
9 SUBSTANTIAL MODIFICATION SM-2 2023-11-21 Acceptable 2024-02-05
10 SUBSEQUENT ADDITION OF MSC APP-10 2024-03-27 Acceptable
2023-09-25
 2024-06-24
11 SUBSTANTIAL MODIFICATION SM-5 2024-03-28 Acceptable 2024-05-02
12 SUBSTANTIAL MODIFICATION SM-6 2024-11-15 Austria Acceptable
2025-03-03
 2025-03-03
13 SUBSTANTIAL MODIFICATION SM-9 2025-07-03 Acceptable 2025-08-26
14 NON SUBSTANTIAL MODIFICATION NSM-13 2025-09-23 Acceptable 2025-09-23
15 SUBSEQUENT ADDITION OF MSC APP-15 2025-09-24 2025-12-15
16 SUBSTANTIAL MODIFICATION SM-10 2025-10-24 Acceptable 2025-12-14
17 SUBSTANTIAL MODIFICATION SM-11 2025-12-09 Acceptable 2026-02-13
18 SUBSTANTIAL MODIFICATION SM-12 2026-02-09 Acceptable 2026-04-09
19 SUBSEQUENT ADDITION OF MSC APP-19 2026-02-16 2026-05-11
20 SUBSTANTIAL MODIFICATION SM-13 2026-02-26 Acceptable 2026-05-18
21 SUBSTANTIAL MODIFICATION SM-14 2026-03-04 Acceptable 2026-05-25

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