Trials / Active Not Recruiting
Active Not RecruitingNCT04158934
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 207 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ADYNOVI/ADYNOVATE | Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC. |
Timeline
- Start date
- 2020-07-09
- Primary completion
- 2030-02-28
- Completion
- 2030-02-28
- First posted
- 2019-11-12
- Last updated
- 2026-02-18
Locations
36 sites across 13 countries: United States, Bulgaria, Croatia, Czechia, Germany, Hungary, Italy, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04158934. Inclusion in this directory is not an endorsement.