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

Description

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.

Interventions

• Testing of hepatic AAV Vector integration (Diagnostic test)
  Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated

Eligibility criteria

Conditions

Locations

• The Regents of the University of California||UC Davis Health — Rancho Cordova, California, United States
• UC Davis Health — Sacramento, California, United States
• UC Davis Ambulatory Care Clinic — Sacramento, California, United States
• UC Davis Hemophilia Treatment Center — Sacramento, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSF Outpatient Hematology Clinic — San Francisco, California, United States
• USF Health Morsani Center For Advanced Healthcare — Tampa, Florida, United States
• The University of South Florida Board of Trustees — Tampa, Florida, United States
• Innovative Hematology, Inc. — Indianapolis, Indiana, United States
• Mississippi Center For Advanced Medicine — Madison, Mississippi, United States
• Cornell University||Joan & Sanford I. Weill Medical College — New York, New York, United States
• Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States
• The Childrens Hospital of Philadelphia Division of Hematology — Philadelphia, Pennsylvania, United States
• The Childrens Hospital of Philadelphia Division of Hematology — Philadelphia, Pennsylvania, United States
• Washington Institute for Coagulation — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Sydney Local Health District (RPAH Zone) — Camperdown, New South Wales, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario, Canada
• Hospices Civils de Lyon - Hopital Louis Pradel — Bron, Rhône, France
• Hôpital Universitaire Necker Enfants Malades — Paris, France
• Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
• General Hospital of Athens Laiko — Athens, Greece
• Nagoya University Hospital — Nagoya, Aichi-ken, Japan
• Sapporo Tokushukai Hospital — Sapporo, Hokkaido, Japan
• Saitama Medical University Hospital — Iruma-gun, Saitama, Japan
• King Faisal Specialist Hospital and Research Center — Riyadh, Saudi Arabia
• Kyung Hee University Hospital at Gangdong — Seoul, South Korea
• Hospital Universitario Rio Hortega — Valladolid, Spain
• Skåne University Hospital — Malmö, Sweden
• Changhua Christian Hospital — Changhua, Taiwan
• Chung-Ho Memorial Hospital, Kaohsiung Medical University — Kaohsiung City, Taiwan
• Chung Shan Medical University Hospital — Taichung, Taiwan
• Taichung Veterans General Hospital — Taichung, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Ege Universitesi Hastanesi — Izmir, İ̇zmir, Turkey (Türkiye)
• Acibadem Adana Hospital — Adana, Turkey (Türkiye)
• Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi — Gaziantep, Turkey (Türkiye)
• İstanbul Üniversitesi Onkoloji Enstitüsü — Istanbul, Turkey (Türkiye)