Trials Today

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Male
Accepts Healthy Volunteers: No

Inclusion Criteria

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.

Exclusion Criteria

None

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Non-investigational study
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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	Diagnostic Test: Testing 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
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	Diagnostic Test: Testing 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

Recruiting Locations

UC Davis Health
Sacramento, California 95816

UC Davis Medical Center
Sacramento, California 95817

USF Health Morsani Center For Advanced Healthcare
Tampa, Florida 33612

The University of South Florida Board of Trustees
Tampa, Florida 33620

Cornell University||Joan & Sanford I. Weill Medical College
New York, New York 10065

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

More Details

NCT ID: NCT05568719
Status: Recruiting
Sponsor: Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.