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ACTIVE NOT RECRUITING Phase 3

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

NCT04370054 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • BIOLOGICAL PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy

Study Locations (20)

California

  • NOW Physical Therapy — Mountain View
  • Clinical and Translational Research Unit (CTRU) — Palo Alto
  • Lucile Packard Childrens Hospital — Palo Alto
  • Imaging Clinic at Stanford Medicine Outpatient Center in Redwood City — Redwood City
  • UCSF IDS Pharmacy — San Francisco
  • University of California, San Francisco - Clinical Research Center — San Francisco
  • University of California, San Francisco - Moffitt/Long Inpatient Hematology — San Francisco
  • University of California, San Francisco - Outpatient Hematology Clinic — San Francisco
  • Stanford Health Care — Stanford

Other

  • Hopital Necker — Paris
  • Vivantes Klinikum im Friedrichshain — Berlin
  • Klinikum der Johann Wolfgang Goethe-Universitaet, Medizinische Klinik II — Frankfurt am Main
  • General Hospital of Athens "Hippokration" — Athens

Washington

  • Washington Institute for Coagulation — Seattle
  • University of Washington Medical Center - Translational Research Unit (TRU) — Seattle

Ontario

  • McMaster University Medical Centre - Hamilton Health Sciences — Hamilton
  • Juravinski Hospital - Hamilton Health Sciences — Hamilton

Victoria

  • The Alfred Hospital — Melbourne

São Paulo

  • Centro de Hematologia e Hemoterapia de Campinas - Hemocentro UNICAMP — Campinas

Attikí

  • General Hospital of Athens ''Laiko'' — Athens

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2020-08-18
Est. Completion 2028-10-25
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04370054

The ClinicalTrials.gov registry entry for NCT04370054 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention — of which PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04370054 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Other, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04370054 about?

NCT04370054 is a clinical study titled "Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults". 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 stud...

What is the current status of trial NCT04370054?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2020-08-18. Estimated completion is 2028-10-25.

What conditions does trial NCT04370054 study?

This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04370054?

The interventions under investigation include: PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04370054?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04370054 being conducted?

This trial has 20 study locations across California, Washington, Victoria, São Paulo, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial