Follows adults with hemophilia A or B after past gene therapy
Tracks long-term safety and durability of earlier gene therapy in adults with hemophilia.
Key facts
- Who runs it
- Pfizer Inc.
- Where
- Berlin and Bonn, GermanySee the 2 sitesAlso in 5 other countries, 7 sites
- Trial code
- Registry title
- A Non-Investigational Product, Multi-Center Cohort Study to Describe Long-Term Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 32 people, planned
- Started
- 22 Jul 2026
- Expected to end
- 25 Feb 2040
- Type of study
- Interventional
- Record updated
- 23 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. 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.
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Only participants who received giroctocogene fitelparvovec or fidanacogene elaparvovec and were enrolled in a Pfizer-sponsored study are eligible
Who cannot take part
- None
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Germany
Also in 5 other countries, 7 sites
- Vivantes Klinikum FriedrichshainBerlin, GermanyTaking people
- Universitätsklinikum BonnBonn, GermanyTaking people
About the trial
What the trial wants to find out
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Follows adults with hemophilia A or B after past gene therapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2025-523660-21-00, who can take part
- Record updated
- 23 October 2026