RecruitingPhase 3NCT05568719

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

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


Sponsor

Pfizer

Enrollment

173 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Testing of hepatic AAV Vector integration for people with hemophilia a and hemophilia b. The study is currently recruiting participants at 22 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTesting of hepatic AAV Vector integration

Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated


Locations(23)

The Regents of the University of California||UC Davis Health

Rancho Cordova, California, United States

UC Davis Health

Sacramento, California, United States

UC Davis Ambulatory Care Clinic

Sacramento, California, United States

UC Davis Hemophilia Treatment Center

Sacramento, California, United States

UC Davis Medical Center

Sacramento, California, United States

UCSF Outpatient Hematology Clinic

San Francisco, California, United States

USF Health Morsani Center For Advanced Healthcare

Tampa, Florida, United States

The University of South Florida Board of Trustees

Tampa, Florida, United States

Mississippi Center For Advanced Medicine

Madison, Mississippi, United States

Cornell University||Joan & Sanford I. Weill Medical College

New York, New York, United States

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States

The Childrens Hospital of Philadelphia Division of Hematology

Philadelphia, Pennsylvania, United States

The Childrens Hospital of Philadelphia Division of Hematology

Philadelphia, Pennsylvania, United States

Washington Institute for Coagulation

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Sydney Local Health District (RPAH Zone)

Camperdown, New South Wales, Australia

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Skåne University Hospital

Malmö, Sweden

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Ege Universitesi Hastanesi

Izmir, İ̇zmir, Turkey (Türkiye)

Acibadem Adana Hospital

Adana, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT05568719


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