Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
4
Countries
1
Sites
2
familial polycythemia associated with an EPO gene mutation
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Dijon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 1 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
familial polycythemia associated with an EPO gene mutation
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Dijon
- Sponsor organisation
- Centre Hospitalier Universitaire De Dijon
- Address
- 2 Boulevard Mal De Lattre De Tassigny
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Chef de projets
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Chef de projets
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 4 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Hématologie, 125 Rue De Stalingrad, 93009, Bobigny Cedex
Centre Hospitalier de Macon
Médecine Interne, Boulevard Louis Escande, 71000, Macon
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 |
|---|---|---|---|---|---|
| France | 2025-08-01 | 2025-08-05 | 2026-03-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-30 | France | Acceptable 2025-07-08
|
2025-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-14 | France | Acceptable 2026-04-30
|
2026-04-30 |