Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
4
Sites
9
Haemophilia A
Key facts
- Sponsor
- Swedish Orphan Biovitrum AB (publ)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 15 Jan 2025 → 21 May 2026
- Decision date (initial)
- 2025-12-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505801-17-00
- WHO UTN
- U1111-1292-6071
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Haemophilia A
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10018937 | Haemophilia A | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Swedish Orphan Biovitrum AB (publ)
- Sponsor organisation
- Swedish Orphan Biovitrum AB (publ)
- Address
- -
- City
- Stockholm
- Postcode
- 112 76
- Country
- Sweden
Scientific contact point
- Organisation
- Swedish Orphan Biovitrum AB (publ)
- Contact name
- Contact point
Public contact point
- Organisation
- Swedish Orphan Biovitrum AB (publ)
- Contact name
- Contact point
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 12 | 1 |
| Germany | Ended | 7 | 2 |
| Italy | Ended | 7 | 3 |
| Spain | Ended | 10 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Third Department of Clinical Hematology at Clinical Hematology Clinic, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Universitaetsklinikum Frankfurt AöR
Hematology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Bonn AöR
Experimental Haematology and Transfusion Medicine, Venusberg-Campus 1, Venusberg, Bonn
Azienda Ospedaliera Universitaria Federico II Di Napoli
Unit of Innovative Therapies for Genetic and Metabolic Diseases, Via Sergio Pansini 5, 80131, Naples
Humanitas Research Hospital
Phase I Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Careggi
Center for Bleeding Clinical Trial Unit-1 (CTU-1), Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Complejo Hospitalario Universitario Juan Canalejo
Hematology, Barrio As Xubias 84, 15006, A Coruna
Hospital Unviersitario Miguel Servet
Hematology and Hemotherapy Department, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Hemostasis and Thrombosis Unit, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-02-04 | 2026-05-21 | 2026-02-19 | 2026-04-30 | |
| Germany | 2025-01-15 | 2026-05-21 | 2025-01-20 | 2026-04-30 | |
| Italy | 2025-01-15 | 2026-05-21 | 2025-02-19 | 2026-04-30 | |
| Spain | 2025-01-15 | 2026-05-21 | 2025-02-04 | 2026-04-30 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-23 | Germany | Acceptable 2024-04-02
|
2024-04-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-08 | Germany | Acceptable 2024-09-02
|
2024-09-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-03 | Germany | Acceptable 2024-09-02
|
2024-10-03 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-21 | Germany | Acceptable 2024-09-02
|
2025-01-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-25 | Germany | Acceptable 2024-09-02
|
2025-02-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-30 | Acceptable | 2025-05-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-22 | Germany | Acceptable 2025-10-06
|
2025-10-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-16 | Acceptable | 2025-11-20 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-10-17 | Acceptable 2025-10-06
|
2025-12-18 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-06 | Acceptable | 2026-06-01 |