Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
3
Sites
5
Pulmonary arterial hypertension
Key facts
- Sponsor
- 35Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 29 Oct 2024 → 30 Apr 2025
- Decision date (initial)
- 2024-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pulmonary arterial hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064911 | Pulmonary arterial hypertension | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
35Pharma Inc.
- Sponsor organisation
- 35Pharma Inc.
- Address
- 750 Saint-Laurent Boulevard Suite 101
- City
- Montreal
- Postcode
- H2Y 2Z4
- Country
- Canada
Scientific contact point
- Organisation
- 35Pharma Inc.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- 35Pharma Inc.
- Contact name
- VP of Clinical Operations
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 3 |
| Hungary | Ended | 4 | 1 |
| Poland | Ended | 2 | 1 |
| Rest of world
United States, Canada
|
— | 20 | — |
Investigational sites
Medizinische Hochschule Hannover
Pneumologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitätsmedizin Greifswald
Respiratory Medicine and Infectious Diseases, Ferdinand-Sauerbruchstraße, 17475, Greifswald
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I Abteilung für Pneumologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Semmelweis University
Internal Medicine and Oncology Clinic Department of Clinical Pharmacology, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
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 |
|---|---|---|---|---|---|
| Germany | 2024-10-29 | 2024-11-26 | 2025-02-26 | ||
| Hungary | 2024-11-13 | 2025-02-07 | 2025-02-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-72443
- Halt date
- 2025-02-26
- Member states concerned
- Hungary
- Publication date
- 2025-02-26
- Reason
- Sponsor decision
- Explanation
- A pericardial effusion Grade 3 (SUSAR) has been reported in a subject receiving the study drug. The Sponsor decided to temporarily halt the study out of an abundance of caution and to further review available data.
- Follow-up measures
- Dosing of study drug has been halted for all enrolled patients subject to further data review. No new subjects will be enrolled at this time. Patients who have received at least 1 dose of HS135 are encouraged to remain in the study and perform all study procedures, for at least 2 months after their last dose.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-72445
- Halt date
- 2025-02-26
- Member states concerned
- Germany
- Publication date
- 2025-02-26
- Reason
- Sponsor decision
- Explanation
- A pericardial effusion Grade 3 (SUSAR) has been reported in a subject receiving the study drug. The Sponsor decided to temporarily halt the study out of an abundance of caution and to further review available data.
- Follow-up measures
- Dosing of study drug has been halted for all enrolled patients subject to further data review. No new subjects will be enrolled at this time. Patients who have received at least 1 dose of HS135 are encouraged to remain in the study and perform all study procedures, for at least 2 months after their last dose.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-29 | Poland | Acceptable 2024-06-24
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-15 | Poland | Acceptable 2024-09-24
|
2024-09-30 |