Recruiting
Phase 3

Giroctocogene Fitelparvovec & Fidanacogene Elaparvovec

Sponsor:

Pfizer

Code:

NCT05568719

Conditions

Hemophilia A

Hemophilia B

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Testing of hepatic AAV Vector integration

Study Details

Brief 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.

Conditions

Hemophilia A

Hemophilia B

Study ID

NCT05568719

Start date

Dec 28, 2022

Status verified date

May, 2026

Completion date

Feb 25, 2040

Anticipated

Primary completion date

Feb 25, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

173 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Incidence of thromboembolic events [ Time Frame: Day 1 to 10 years ]
  • Incidence of factor inhibitor development [ Time Frame: Day 1 to 10 years ]
  • Incidence of hepatic malignancy [ Time Frame: Day 1 to 10 years ]
  • Incidence of liver abnormalities [ Time Frame: Day 1 to 10 years ]
  • Factor activity level [ Time Frame: Day 1 to 10 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

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

Recruiting

Rancho Cordova, California, United States, 95670

UC Davis Health

Recruiting

Sacramento, California, United States, 95816

UC Davis Ambulatory Care Clinic

Recruiting

Sacramento, California, United States, 95817

UC Davis Hemophilia Treatment Center

Recruiting

Sacramento, California, United States, 95817

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

USF Health Morsani Center For Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

The University of South Florida Board of Trustees

Recruiting

Tampa, Florida, United States, 33620

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

Recruiting

New York, New York, United States, 10065

Weill Cornell Medical College-New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

The Childrens Hospital of Philadelphia Division of Hematology

Recruiting

Philadelphia, Pennsylvania, United States, 19104

The Childrens Hospital of Philadelphia Division of Hematology

Recruiting

Philadelphia, Pennsylvania, United States, 19146

More Information

Sponsor

Pfizer

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • bleeding
  • adeno-associated virus based vector
  • gene therapy
  • giroctocogene fitelparvovec
  • fidanacogene elaparvovec
  • factor VIII
  • factor IX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-27.