Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
100,000
Countries
5
Sites
34
Acute critical illness requiring intensive care unit admission.
The Intensive Care Platform Trial (INCEPT) will assess the effects of interventions used in adults acutely admitted to the intensive care unit. INCEPT will primarily focus on interventions in common use where practice differs among clinicians, but other interventions may similarly be assessed on the platform.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Trial duration
- 26 Jun 2025 → ongoing
- Decision date (initial)
- 2025-02-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sygeforsikringen ’danmark’ · Savværksejer Jeppe Juhl og hustru Ovita Juhls Mindelegat · Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond · Danmarks Frie Forskningsfond · The Novo Nordisk Foundation · Dagmar Marshalls Fond
External identifiers
- EU CT number
- 2024-516208-41-00
- WHO UTN
- U1111-1313-8171
- ClinicalTrials.gov
- NCT06667999
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The Intensive Care Platform Trial (INCEPT) will assess the effects of interventions used in adults acutely admitted to the intensive care unit.
INCEPT will primarily focus on interventions in common use where practice differs among clinicians, but other interventions may similarly be assessed on the platform.
Conditions and MedDRA coding
Acute critical illness requiring intensive care unit admission.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10022519 | Intensive care | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Adult patient (≥18 years old) acutely admitted to the ICU.
- Eligible for at least one active domain.
Exclusion criteria 2
- Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).
- Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol).
Secondary endpoints 12
- All-cause 30-day mortality
- All-cause 90-day mortality
- All-cause 180-day mortality
- Days alive without life support at day 30
- Days alive without life support at day 90
- Days alive out of hospital at day 30
- Days alive out of hospital at day 90
- Days free of delirium at day 30
- EQ-5D-5L index values (health-related quality of life) at day 180
- EQ VAS (health-related quality of life) at day 180
- Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”])
- One or more domain-specific safety outcomes
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Innohep, injektionsvæske, opløsning i fyldt injektionssprøjte 2.500 anti-Xa IE
PRD5309759 · Product
- Active substance
- Tinzaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 8000 IU international unit(s)
- Max total dose
- 720000 IU international unit(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB10 — TINZAPARIN
- Marketing authorisation
- 57953
- MA holder
- LEO PHARMA A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fragmin, injektionsvæske, opløsning i fyldt injektionssprøjte med nålebeskytter
PRD12105505 · Product
- Active substance
- Dalteparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10000 IU international unit(s)
- Max total dose
- 900000 IU international unit(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- 54982
- MA holder
- PFIZER APS
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Human Albumin ”CSL Behring”, infusionsvæske, opløsning 20 %
PRD331338 · Product
- Active substance
- Human Plasma Proteins with Not Less Than 96% Albumin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 l litre(s)
- Max total dose
- 30 l litre(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05AA01 — ALBUMIN
- Marketing authorisation
- 35991
- MA holder
- CSL BEHRING GMBH
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Human Albumin ”CSL Behring”, infusionsvæske, opløsning 5 %
PRD331499 · Product
- Active substance
- Human Plasma Proteins with Not Less Than 96% Albumin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 l litre(s)
- Max total dose
- 30 l litre(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05AA01 — ALBUMIN
- Marketing authorisation
- 35990
- MA holder
- CSL BEHRING GMBH
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fraxiparine 2.850 IE/ 0,3 ml oplossing voor injectie
PRD8958975 · Product
- Active substance
- Nadroparin Calcium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 7600 IU international unit(s)
- Max total dose
- 684000 IU international unit(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB06 — NADROPARIN
- Marketing authorisation
- RVG 11876
- MA holder
- MYLAN HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Enoxaparin "Becat", injektionsvæske, opløsning i fyldt injektionssprøjte
PRD6094045 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- 59805
- MA holder
- LABORATORIOS FARMACÉUTICOS ROVI, S.A
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Anders Perner
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Rikke Larsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
5 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20,000 | 21 |
| Finland | Authorised, recruitment pending | 20,000 | 4 |
| Iceland | Authorised, recruitment pending | 20,000 | 1 |
| Netherlands | Authorised, recruitment pending | 20,000 | 5 |
| Sweden | Authorised, recruitment pending | 20,000 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Aalborg University Hospital
Department of Anesthesia and Intensive Care, Hobrovej 18-22, 9000, Aalborg
Region Midtjylland
Department of Intensive Care, Skovlyvej 15, 8930, Randers Noe
Region Midtjylland
Department of Intensive Care, Øst, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Dept. of Anesthesiology and Intensive Care Medicine, Baagoees Alle 15, 5700, Svendborg
Lillebaelt Hospital
Department of Anesthesia and Intensive Care Medicine, Sygehusvej 24, 6000, Kolding
Region Sjaelland
Department of Anesthesia, Lykkebaekvej 1, 4600, Koege
Sygehus Soenderjylland Soenderborg
Department of Anaesthesia, Kresten Philipsens Vej 15, 6200, Aabenraa
Rigshospitalet
Department of Intensive Care, Blegdamsvej 9, 2100, Copenhagen Oe
Region Sjaelland
Department of Intensive Care, Fjordvej 15, 4800, Nykoebing F
Copenhagen University Hospital
Department of Cardiothoracic Anaesthesia and Intensive Care, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Department of Anaestesiology and Intensive Care, Heibergs Alle 4, 8800, Viborg
Hvidovre Hospital
Department of Intensive Care, Kettegaard Alle 30, 2650, Hvidovre
Copenhagen University Hospital
Department of Anestesiology and Intensive Care, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Copenhagen University Hospital
Department of Intensive Care, Ringvej 75, 2730, Herlev
Copenhagen University Hospital
Department of Neuroanaesthesiology, Blegdamsvej 9, 2100, Copenhagen Oe
Hillerod Hospital
Department of Intensive Care, Dyrehavevej 29, 3400, Hilleroed
Region Midtjylland
Department of Intensive Care, Nord, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Midtjylland
Department of Anaesthesiology and Intensive Care, Hospitalsparken 15, 7400, Herning
Odense University Hospital
Department of Anesthesiology and Intensive Care, J B Winsloews Vej 4, 5000, Odense C
Slagelse Hospital
Department of Intensive Care, Ingemannsvej 18, 4200, Slagelse
Esbjerg Og Grindsted Sygehus
Department of Anesthesiology and Intensive Care, Finsensgade 35, 6700, Esbjerg
Pirkanmaan hyvinvointialue
Anaesthesiology and Intensive Care Medicine, Elamanaukio 2, 33520, Tampere
HUS-yhtymae
Perioperative and Intensive Care, Haartmaninkatu 4, 00290, Helsinki
Pohjois-Savon hyvinvointialue
Department of Anaesthesiology and Intensive Care, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
Wellbeing Services County Of Central Finland
rtment of Anesthesiology and Intensive Care, Hoitajantie 3, 40620, Jyvaskyla
Landspitali
Department of Anaesthesiology and Critical Care Medicine, Hringbraut 101, 101, Reykjavik
Academisch Ziekenhuis Maastricht
Intensive Care Medicine, P Debyelaan 25, 6229 HX, Maastricht
Antonius ziekenhuis Sneek
Anesthesiology and Intensive Care, Bolswarderbaan 1, 8601 ZK, Sneek
Stichting Martini Ziekenhuis
Intensive Care, Van Swietenplein 1, 9728 NT, Groningen
Ziekenhuis Nij Smellinghe
Anesthesiology and Intensive Care, Compagnonsplein 1, 9202 NN, Drachten
Universitair Medisch Centrum Groningen
Critical Care, Hanzeplein 1, 9713 GZ, Groningen
Danderyds Sjukhus AB
Department of Anaesthesia and Intensive Care, Entrevagen 2, 182 57, Danderyd
Region Skane Skanes Universitetssjukhus
Intensive and Perioperative Care, Jan Waldenstroms Gata 16 Plan 5, Malmo St Johannes, Malmo
Karolinska University Hospital
Perioperativ Medicin och Intensivvård, Eugeniavagen 3, 171 64, Solna
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-06-26 | 2025-06-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 101 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_INCEPT core protocol v1_4 20250820 | 1.4 |
| Protocol (for publication) | D1_INCEPT core protocol v1_4 20250820_tracked changes | 1.4 |
| Protocol (for publication) | D1_INCEPT national appendix - Denmark v1_4 20250820_tracked changes | 1.4 |
| Protocol (for publication) | D1_INCEPT national appendix - Denmark v1_4 20250820 | 1.4 |
| Protocol (for publication) | D1_INCEPT-Albumin Domain-specific appendix v1_4 20250820 | 1.4 |
| Protocol (for publication) | D1_INCEPT-Albumin Domain-specific appendix v1_4 20250820_tracked changes | 1.4 |
| Protocol (for publication) | D1_INCEPT-Thromboprophylaxis Domain-specific appendix v1_1 20250820 | 1.1 |
| Protocol (for publication) | D1_INCEPT-Thromboprophylaxis Domain-specific appendix v1_1 20250820_tracked changes | 1.1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-VAS | 1 |
| Protocol (for publication) | D4_Patient facing documents MoCA 5 min T version 2_1 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_NL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements INCEPT Sweden | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements_Iceland | 1 |
| Subject information and informed consent form (for publication) | L1 SIS_INCEPT-Thromboprophylaxis Information forsgsvrge DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1 SIS_INCEPT-Thromboprophylaxis Information parrende DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1 SIS_INCEPT-Thromboprophylaxis Information patient DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket forgsvrge DK v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket forsgsvrge DK v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket parrende DK v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket parrende DK v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket patient DK v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Albumin Samtykkeblanket patient DK v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Thromboprophylaxis Samtykkeblanket forsgsvrge DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Thromboprophylaxis Samtykkeblanket parrende DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF INCEPT-Thromboprophylaxis Samtykkeblanket patient DK v1_0 2024-516208-41-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Participant_ use existing data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Participant_cont coll data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Patient_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Patient_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Relative_cont coll data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Relative_use existing data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Relative_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Albumin_Consent_Relative_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Participant_cont coll data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Participant_use existing data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Patient_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Patient_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Relative_cont coll data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Relative_use existing data_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Relative_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_IS INCEPT-Thromboprophylaxis_Consent_Relative_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_Samtyckesformular_INCEPT-Albumin v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_Samtyckesformular_INCEPT-Trombosprofylax v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief patient 2024-516208-41-00 | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief patient 2024-516208-41-00_TC | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief patient achteraf 2024-516208-41-00 | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief patient achteraf 2024-516208-41-00_TC | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief wettelijk vertegenwoordiger 2024-516208-41-00 | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_INCEPT_NL_informatiebrief wettelijk vertegenwoordiger 2024-516208-41-00_TC | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS INCEPT Information parrende DK v1_4 2024-516208-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS INCEPT Information patient DK v1_4 2024-516802-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT_next of kin_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT_study participant_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT-Albumin_next of kin_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT-Albumin_study participant_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT-Thromboprophylaxis_next of kin_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_INCEPT-Thromboprophylaxis_study particpant_v2_0 2024-516208-41-00_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT Information forsgsvrge DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT Information forsgsvrge DK v1_4_02024-516208-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT Information parrende DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT Information patient DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT information v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT information v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information forsgsvrge DK v1_4 2024-516208-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information forsgsvrge DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information parrende DK v1_4 2024-516208-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information parrende DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information patient DK v1_4 2024-516208-41-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin Information patient DK v1_4 2024-516208-41-00_tracked changes | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin information v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Albumin information v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Trombosprofylax information v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_INCEPT-Trombosprofylax information v1_1 2024-516208-41-00_tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT Information_Patient_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT Information_Patient_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT Information_Relatives_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT Information_Relatives_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Albumin Information_Patient_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Albumin Information_Patient_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Albumin Information_Relatives_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Thromboprophylaxis Information_Patient_v1_0 2024-516208-41-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Thromboprophylaxis Information_Relatives_v1_1 2024-516208-41-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_IS INCEPT-Thromboprophylaxis Information_Relatives_v1_1 2024-516208-41-00_TC | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material information leaflet adult | 02/02/2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Enoxaparin Becat_injektionsvske_oplsning i fyldt injektionssprjte | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fragmin_injektionsvske_oplsning i fyldt injektionssprjte med nalebeskytter | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fraxiparine_Dutch | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fraxiparine_English | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Human Albumin CSL Behring infusionsvske oplsning 20 procent | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Human Albumin CSL Behring infusionsvske oplsning 5 procent | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Innohep_injektionsvske_oplsning i fyldt injektionssprjte | 1 |
| Synopsis of the protocol (for publication) | D1_INCEPT core protocol synopsis v1_4 20250820 | 1.4 |
| Synopsis of the protocol (for publication) | D1_INCEPT core protocol synopsis v1_4 20250820_tracked changes | 1.4 |
| Synopsis of the protocol (for publication) | D1_INCEPT-Albumin synopsis v1_4 20250820 | 1.4 |
| Synopsis of the protocol (for publication) | D1_INCEPT-Albumin synopsis v1_4 20250820_tracked changes | 1.4 |
| Synopsis of the protocol (for publication) | D1_INCEPT-Thromboprophylaxis synopsis v1_1 20250820 | 1.1 |
| Synopsis of the protocol (for publication) | D1_INCEPT-Thromboprophylaxis synopsis v1_1 20250820_tracked changes | 1.1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-07 | Denmark | Acceptable 2025-02-17
|
2025-02-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-27 | Denmark | Acceptable 2025-08-29
|
2025-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-01 | Denmark | Acceptable | 2025-12-22 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-12-12 | 2026-03-20 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-12-15 | 2026-02-27 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-12-17 | 2026-03-30 | ||
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-12-18 | Acceptable 2025-08-29
|
2026-03-18 |