Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively (NCT05568719)
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-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The Regents of the University of California||UC Davis Health — Rancho Cordova, California
Age range: 18 Years
🧪 Interventions in This Study
- Testing of hepatic AAV Vector integration (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- The Regents of the University of California||UC Davis Health — Rancho Cordova, California
- UC Davis Health — Sacramento, California
- UC Davis Ambulatory Care Clinic — Sacramento, California
- UC Davis Hemophilia Treatment Center — Sacramento, California
- UC Davis Medical Center — Sacramento, California
- UCSF Outpatient Hematology Clinic — San Francisco, California
- USF Health Morsani Center For Advanced Healthcare — Tampa, Florida
- The University of South Florida Board of Trustees — Tampa, Florida
- Mississippi Center For Advanced Medicine — Madison, Mississippi
- Cornell University||Joan & Sanford I. Weill Medical College — New York, New York
- Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York
- The Childrens Hospital of Philadelphia Division of Hematology — Philadelphia, Pennsylvania
- The Childrens Hospital of Philadelphia Division of Hematology — Philadelphia, Pennsylvania
- Washington Institute for Coagulation — Seattle, Washington
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Sydney Local Health District (RPAH Zone) — Camperdown, New South Wales
- Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario
- Kyung Hee University Hospital at Gangdong — Seoul,
- Skåne University Hospital — Malmö,
- Taichung Veterans General Hospital — Taichung,
- National Taiwan University Hospital — Taipei,
- Ege Universitesi Hastanesi — Izmir, İ̇zmir
- Acibadem Adana Hospital — Adana,
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hemophilia A
- Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" — Little Rock, Arkansas
- Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A — Los Angeles, California
- Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A — Milwaukee, Wisconsin
- A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A — Gainesville, Florida
- A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A — Gilbert, Arizona
- Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults — Mountain View, California
Explore by condition: All Hemophilia A clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.