Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
6
Countries
2
Sites
2
Treatment of patients with Hemophilia A who have developed inhibitory antibodies to clotting Factor VIII and have failed Immune Tolerance Induction
Key facts
- Sponsor
- Cell4Cure AB
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 13 Oct 2022 → ongoing
- Decision date (initial)
- 2022-12-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502030-12-01
- EudraCT number
- 2021-000608-39
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of patients with Hemophilia A who have developed inhibitory antibodies to clotting Factor VIII and have failed Immune Tolerance Induction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10053751 | Hemophilia A with anti factor VIII | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cell4Cure AB
- Sponsor organisation
- Cell4Cure AB
- Address
- Gustav IIIs Boulevard 10
- City
- Solna
- Postcode
- 169 72
- Country
- Sweden
Scientific contact point
- Organisation
- Cell4Cure AB
- Contact name
- CEO
Public contact point
- Organisation
- Cell4Cure AB
- Contact name
- CEO
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruiting | 2 | 1 |
| Sweden | Authorised, recruitment pending | 2 | 1 |
| Rest of world
United Kingdom
|
— | 2 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Norway | 2022-10-13 | ||||
| Sweden |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-26 | Sweden | Acceptable 2022-12-01
|
2022-12-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-01-19 | Sweden | Acceptable 2023-04-19
|
2023-04-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-13 | Sweden | Acceptable 2024-03-15
|
2024-03-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-25 | Sweden | Acceptable 2024-08-28
|
2024-08-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-17 | Sweden | Acceptable 2025-03-18
|
2025-03-19 |