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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible.
Locations
United States
California
UC Davis Ambulatory Care Clinic
RECRUITING
Sacramento
UC Davis Health
RECRUITING
Sacramento
UC Davis Hemophilia Treatment Center
RECRUITING
Sacramento
UC Davis Medical Center
RECRUITING
Sacramento
UCSF Outpatient Hematology Clinic
NOT_YET_RECRUITING
San Francisco
Florida
USF Health Morsani Center For Advanced Healthcare
RECRUITING
Tampa
Mississippi
Mississippi Center For Advanced Medicine
TERMINATED
Madison
New York
Weill Cornell Medical College-New York Presbyterian Hospital
RECRUITING
New York
Pennsylvania
The Childrens Hospital of Philadelphia Division of Hematology
RECRUITING
Philadelphia
Washington
Washington Institute for Coagulation
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Turkey
Ege Universitesi Hastanesi
RECRUITING
Izmir
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-12-28
Estimated Completion Date: 2040-02-25
Participants
Target number of participants: 263
Treatments
Other: Hemophilia A / giroctocogene fitelparvovec
Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study
Other: Hemophilia B / fidanacogene elaparvovec
Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study
Related Therapeutic Areas
Sponsors
Leads: Pfizer