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

Description

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.

Conditions

Hemophilia A, Hemophilia B

Study Overview

Study Details

Study overview

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.

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

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

Condition
Hemophilia A
Intervention / Treatment

-

Contacts and Locations

Sacramento

UC Davis Health, Sacramento, California, United States, 95816

Sacramento

UC Davis Ambulatory Care Clinic, Sacramento, California, United States, 95817

Sacramento

UC Davis Hemophilia Treatment Center, Sacramento, California, United States, 95817

Sacramento

UC Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

UCSF Outpatient Hematology Clinic, San Francisco, California, United States, 94143

Tampa

USF Health Morsani Center For Advanced Healthcare, Tampa, Florida, United States, 33612

Madison

Mississippi Center For Advanced Medicine, Madison, Mississippi, United States, 39110

Philadelphia

The Childrens Hospital of Philadelphia Division of Hematology, Philadelphia, Pennsylvania, United States, 19104

Seattle

Washington Institute for Coagulation, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    MALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Pfizer,

    Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

    Study Record Dates

    2039-09-03