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

Running, not enrolling · Phase 3

Conditions studied: Hemophilia A

In brief

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:C≤1%) 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.

Key facts

Study ID

NCT04370054

Run by

Pfizer

People needed

77

Starts

2020-08-18

Expected to finish

2026-10-25

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

Where it is running

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

Full record on ClinicalTrials.gov

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