Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
26
Countries
2
Sites
5
Hemophilia A
Key facts
- Sponsor
- Sanofi-Aventis Research & Development
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- completed 24 Sep 2024
- Decision date (initial)
- 2024-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502414-84-00
- WHO UTN
- U1111-1280-7227
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hemophilia A
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10060612 | Hemophilia A | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Research & Development
- Sponsor organisation
- Sanofi-Aventis Research & Development
- Address
- 1 Avenue Pierre Brossolette
- City
- Chilly Mazarin
- Postcode
- 91380
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 3 | 2 |
| Spain | Ended | 3 | 3 |
| Rest of world
Taiwan, Mexico, United States
|
— | 20 | — |
Investigational sites
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Centro Emofilia e Trombosi, Via Francesco Sforza 28, 20122, Milan
Humanitas Research Hospital
U.O. Centro Trombosi e Malattie Emorragiche, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Universitario La Paz
Haematology, Paseo Castellana 261, 28046, Madrid
Hospital Unviersitario Miguel Servet
Hemostasis and Thrombosis, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Complexo Hospitalario Universitario A Coruna
Hemostasis and Thrombosis, Lugar Jubias De Arriba 84, 15006, A Coruna
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-06 | Spain | Acceptable with conditions 2024-02-05
|
2024-02-05 |