Under construction – not a live service
Sign in

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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Vivantes Klinikum FriedrichshainBerlinGermanyRecruiting
Universitätsklinikum BonnBonnGermanyRecruiting
Hospital Clínico Universitario Virgen de la ArrixacaEl Palmar, MurciaSpainNot yet recruiting
Hospital Universitario Rio HortegaValladolidSpainNot yet recruiting
Hospices Civils de Lyon - Hopital Louis PradelBronFranceRecruiting
Hôpital Universitaire Necker Enfants MaladesParisFranceRecruiting
Laiko General Hospital of AthensAthensGreeceRecruiting
Azienda Ospedaliera Universitaria Federico IINapoliItalyNot yet recruiting
Skåne University Hospital, Department of Hematology, Oncology and Radiation PhysicsMalmöSwedenRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.