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Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
Sponsor: Pfizer
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.
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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
173
Start Date
2022-12-28
Completion Date
2040-02-25
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Testing of hepatic AAV Vector integration
Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated
Locations (39)
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)