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NCT05568719RecruitingPhase 3

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

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: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
173 (estimated)
First submitted
3 Oct 2022
Start date
28 Dec 2022
Primary completion date
25 Feb 2040
Lead sponsor
Pfizer
Diseases
Haemophilia
NCT number
NCT05568719

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 173
  • From 28 Dec 2022 to the primary completion date, 25 Feb 2040
  • 38 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov 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 investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Prince Alfred Hospital
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
Sydney Local Health District (RPAH Zone)
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Unity Health Toronto, St. Michael's Hospital
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Universitätsklinikum Bonn
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BonnGermanyRecruiting
Hospital Universitario Rio Hortega
Coordinator of this site? Confirm its status
ValladolidSpainRecruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Coordinator of this site? Confirm its status
BronFranceRecruiting
Hôpital Universitaire Necker Enfants Malades
Coordinator of this site? Confirm its status
ParisFranceRecruiting
General Hospital of Athens "Laiko"
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AthensGreeceRecruiting
Saitama Medical University Hospital
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Iruma-gunJapanRecruiting
Nagoya University Hospital
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NagoyaJapanRecruiting
Sapporo Tokushukai Hospital
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SapporoJapanRecruiting
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaRecruiting
King Faisal Specialist Hospital and Research Center
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RiyadhSaudi ArabiaNot yet recruiting
Skåne University Hospital
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MalmöSwedenRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
Chung Shan Medical University Hospital
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TaichungTaiwanNot yet recruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Innovative Hematology, Inc.
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Mississippi Center for Advanced Medicine
Coordinator of this site? Confirm its status
MadisonUnited StatesTerminated
Cornell University||Joan & Sanford I. Weill Medical College
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Weill Cornell Medical College-New York Presbyterian Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
The Childrens Hospital of Philadelphia Division of Hematology
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
The Regents of the University of California||UC Davis Health
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Rancho CordovaUnited StatesRecruiting
UC Davis Health
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SacramentoUnited StatesRecruiting
UC Davis Ambulatory Care Clinic
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SacramentoUnited StatesRecruiting
UC Davis Hemophilia Treatment Center
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SacramentoUnited StatesRecruiting
UC Davis Medical Center
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SacramentoUnited StatesRecruiting
UCSF Outpatient Hematology Clinic
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San FranciscoUnited StatesRecruiting
Washington Institute for Coagulation
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SeattleUnited StatesRecruiting
The University of South Florida Board of Trustees
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TampaUnited StatesRecruiting
USF Health Morsani Center for Advanced Healthcare
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TampaUnited StatesRecruiting
Acibadem Adana Hospital
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AdanaTurkey (Türkiye)Recruiting
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Coordinator of this site? Confirm its status
GaziantepTurkey (Türkiye)Recruiting
Istanbul Universitesi Onkoloji Enstitusu
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Ege Universitesi Hastanesi
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting

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