🏛️ Verified NIH Record • Updated 2026-05-25

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

🟢 Recruiting Phase3 📋 Clinical Research Protocol Sponsor: Pfizer

🩺 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 Checklist

Full 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.

Explore by condition: All Hemophilia A clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗