Long-term follow-up of gene therapy for hemophilia A or B
Follows people with hemophilia A or B after earlier gene therapy treatment.
Key facts
- Who runs it
- Pfizer
- Where
- Adana, Gaziantep, Istanbul, and Izmir, TürkiyeSee the 4 sitesAlso in 12 other countries, 34 sites
- Trial code
- Registry title
- Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 173 people, planned
- Started
- 28 Dec 2022
- Expected to end
- 25 Feb 2040
- Type of study
- Interventional, 2 groups
- Treatments tested
- Testing of hepatic AAV Vector integration
- Record updated
- 7 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 men with hemophilia A or B who already received giroctocogene fitelparvovec or fidanacogene elaparvovec in an earlier Pfizer-sponsored study. It follows their long-term safety and results.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Hemophilia A or hemophilia B
- Earlier treatment
- Must have received giroctocogene fitelparvovec or fidanacogene elaparvovec in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003).
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- -Only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible
Who cannot take part
- -None
Where in Türkiye
Also in 12 other countries, 34 sites
- Acibadem Adana HospitalAdana, TürkiyeTaking people
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama HastanesiGaziantep, TürkiyeTaking people
- Istanbul Universitesi Onkoloji EnstitusuIstanbul, TürkiyeTaking people
- Ege Universitesi HastanesiIzmir, TürkiyeTaking people
About the trial
What the trial wants to find out
A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.
The 2 groups in the trial
- Hemophilia A / giroctocogene fitelparvovecOther group
Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study
Treatment: Testing of hepatic AAV Vector integration
- Hemophilia B / fidanacogene elaparvovecOther group
Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study
Treatment: Testing of hepatic AAV Vector integration
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 → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Long-term follow-up of gene therapy for hemophilia A or BGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 October 2026