Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Immune Thrombocytopenia Purpura
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immune Thrombocytopenia Purpura
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10074667 | Immune thrombocytopenic purpura | 10005329 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 13 Quai Jules Guesde
- City
- Vitry Sur Seine
- Postcode
- 94400
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Germany | Acceptable 2026-05-08
|
2026-05-11 |