๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-31

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults (NCT04370054)

Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants With Moderately Severe to Severe Hemophilia A(FVIII:Cโ‰ค1%)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Pfizer

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:Cโ‰ค1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.

Who can join: Review the eligibility criteria below.

Location: NOW Physical Therapy โ€” Mountain View, California

Age range: 18 Years to 64 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

  • NOW Physical Therapy โ€” Mountain View, California
  • Regents of The University of California โ€” Oakland, California
  • Clinical and Translational Research Unit (CTRU) โ€” Palo Alto, California
  • Lucile Packard Childrens Hospital โ€” Palo Alto, California
  • Imaging Clinic at Stanford Medicine Outpatient Center in Redwood City โ€” Redwood City, California
  • The Board of Trustees of the Leland Stanford Junior University โ€” Redwood City, California
  • UCSF Outpatient Radiology. โ€” San Francisco, California
  • UCSF IDS Pharmacy โ€” San Francisco, California
  • UCSF lnvestigational Drug Service โ€” San Francisco, California
  • UCSF Outpatient Radiology (alternate location) โ€” San Francisco, California
  • UCSF Outpatient Radiology โ€” San Francisco, California
  • University of California, San Francisco - Clinical Research Center โ€” San Francisco, California
  • University of California, San Francisco - Moffitt/Long Inpatient Hematology โ€” San Francisco, California
  • University of California, San Francisco - Outpatient Hematology Clinic โ€” San Francisco, California
  • Access Sourcecorp Deliverex (off-site storage) โ€” San Jose, California
  • Stanford Health Care (hospital and IDS pharmacy) โ€” Stanford, California
  • Stanford Health Care โ€” Stanford, California
  • Washington Institute for Coagulation โ€” Seattle, Washington
  • University of Washington Medical Center - Translational Research Unit (TRU) โ€” Seattle, Washington
  • The Alfred Hospital โ€” Melbourne, Victoria
  • Universidade Estadual de Campina โ€” Campina,
  • Hamilton Health Sciences Corporation โ€” Hamilton, Ontario
  • McMaster University Medical Centre - Hamilton Health Sciences โ€” Hamilton, Ontario
  • Juravinski Hospital - Hamilton Health Sciences โ€” Hamilton, Ontario
  • Hopital Necker โ€” Paris,

๐Ÿ’ฐ 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 ยง 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

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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.
๐Ÿ›๏ธ View Official NIH Record โ†—