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Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
Sponsor: Pfizer
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.
Official title: 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:C≤1%)
Key Details
Gender
MALE
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2020-08-18
Completion Date
2028-10-25
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy
Single IV infusion
Locations (36)
NOW Physical Therapy
Mountain View, 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
UCSF IDS Pharmacy
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
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
Centro de Hematologia e Hemoterapia de Campinas - Hemocentro UNICAMP
Campinas, São Paulo, Brazil
McMaster University Medical Centre - Hamilton Health Sciences
Hamilton, Ontario, Canada
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, Canada
Hopital Necker
Paris, France
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet, Medizinische Klinik II
Frankfurt am Main, Germany
General Hospital of Athens ''Laiko''
Athens, Attikí, Greece
General Hospital of Athens "Hippokration"
Athens, Greece
Università degli studi di Roma "La Sapienza"- Policlinico Umberto I
Roma, RM, Italy
Azienda Ospedaliero Universitaria Careggi SODc Malattie Emorragiche e della Coagulazione
Florence, Italy
Dip. di Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II - UOC di Medicina
Naples, Italy
Nagoya University Hospital - Transfusion Medicine
Nagoya, Aichi-ken, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
H.U. Rio Hortega
Valladolid, Spain
Skåne University Hospital
Malmo, Skåne County, Sweden
National Taiwan University Hospital
Taipei, Taiwan
Adana Acibadem Hospital
Adana, Turkey (Türkiye)
Gaziantep University Sahinbey Research and Training Hospital
Gaziantep, Turkey (Türkiye)
Ege University Medical Faculty, Pediatric Hematology
Izmir, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom