2025-523660-21-00RecruitingPhase 3
A Non-Investigational Product, Multi-Center Cohort Study to Describe Long-Term Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec
C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026
Brief summary (registry, in English)
To characterize the long-term safety of participants who have received prior treatment with giroctocogene fitelparvovec or fidanacogene elaparvovec To describe durability of transgene expression of giroctocogene fitelparvovec or fidanacogene elaparvovec
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 22 Jul 2026
- Lead sponsor
- Pfizer Inc.
- Diseases
- Haemophilia
- EU CT number
- 2025-523660-21-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 32
- 9 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with hemophilia A or B who already got giroctocogene fitelparvovec or fidanacogene elaparvovec in an earlier Pfizer study. It follows their long-term safety and results.
- Age
- 18 to 64 years
- Sex
- Men only
- Disease stage
- Hemophilia A or hemophilia B. The hemophilia B listing says severe to moderately severe (FIX:C ≤ 2%).
- Earlier treatment
- Must have received giroctocogene fitelparvovec or fidanacogene elaparvovec in a Pfizer-sponsored study.
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- Only participants who received giroctocogene fitelparvovec or fidanacogene elaparvovec and were enrolled in a Pfizer-sponsored study are eligible.
Age in the registry: 18 years to 64 years · Sex: Male · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivantes Klinikum Friedrichshain | Berlin | Germany | Recruiting |
| Universitätsklinikum Bonn | Bonn | Germany | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar, Murcia | Spain | Not yet recruiting |
| Hospital Universitario Rio Hortega | Valladolid | Spain | Not yet recruiting |
| Hospices Civils de Lyon - Hopital Louis Pradel | Bron | France | Recruiting |
| Hôpital Universitaire Necker Enfants Malades | Paris | France | Recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Recruiting |
| Azienda Ospedaliera Universitaria Federico II | Napoli | Italy | Not yet recruiting |
| Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics | Malmö | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.