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NCT05568719PHASE3Recruiting

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

Pfizer

Start Date

12/28/2022

Completion Date

2/25/2040

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: -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. Exclusion Criteria: -None

Interventions

DIAGNOSTIC_TEST

Testing of hepatic AAV Vector integration

Interested in This Trial?

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Conditions

Hemophilia AHemophilia B

Locations

The Regents of the University of California||UC Davis Health

Rancho Cordova, California 95670

United States

UC Davis Health

Sacramento, California 95816

United States

UC Davis Ambulatory Care Clinic

Sacramento, California 95817

United States

UC Davis Hemophilia Treatment Center

Sacramento, California 95817

United States

UC Davis Medical Center

Sacramento, California 95817

United States

UCSF Outpatient Hematology Clinic

San Francisco, California 94143

United States

USF Health Morsani Center For Advanced Healthcare

Tampa, Florida 33612

United States

The University of South Florida Board of Trustees

Tampa, Florida 33620

United States

Mississippi Center For Advanced Medicine

Madison, Mississippi 39110

United States

Cornell University||Joan & Sanford I. Weill Medical College

New York, New York 10065

United States

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York 10065

United States

The Childrens Hospital of Philadelphia Division of Hematology

Philadelphia, Pennsylvania 19104

United States

The Childrens Hospital of Philadelphia Division of Hematology

Philadelphia, Pennsylvania 19146

United States

Washington Institute for Coagulation

Seattle, Washington 98101

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Sydney Local Health District (RPAH Zone)

Camperdown, New South Wales 2050

Australia

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Kyung Hee University Hospital at Gangdong

Seoul, 05278

South Korea

Skåne University Hospital

Malmö, 21428

Sweden

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 10041

Taiwan

Ege Universitesi Hastanesi

Izmir, İ̇zmir 35100

Turkey (Türkiye)

Acibadem Adana Hospital

Adana, 01130

Turkey (Türkiye)