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

ClinicalTrials.gov ID: NCT05568719

Public ClinicalTrials.gov record NCT05568719. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 29, 2026, 10:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT05568719
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Pfizer; Industry
Enrollment: 173 participants

Conditions and interventions

Conditions

Interventions

Testing of hepatic AAV Vector integration Diagnostic Test

Diagnostic Test

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 27, 2022
Primary completion: Feb 24, 2040
Completion: Feb 24, 2040
Last update posted: Apr 27, 2026

2022 – 2040

United States locations

U.S. sites: 13
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
The Regents of the University of California\|\|UC Davis Health	Rancho Cordova	California	95670	Recruiting
UC Davis Health	Sacramento	California	95816	Recruiting
UC Davis Ambulatory Care Clinic	Sacramento	California	95817	Recruiting
UC Davis Hemophilia Treatment Center	Sacramento	California	95817	Recruiting
UC Davis Medical Center	Sacramento	California	95817	Recruiting
UCSF Outpatient Hematology Clinic	San Francisco	California	94143	Not yet recruiting
USF Health Morsani Center For Advanced Healthcare	Tampa	Florida	33612	Recruiting
The University of South Florida Board of Trustees	Tampa	Florida	33620	Recruiting
Mississippi Center For Advanced Medicine	Madison	Mississippi	39110	Terminated
Cornell University\|\|Joan & Sanford I. Weill Medical College	New York	New York	10065	Recruiting
Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York	10065	Recruiting
The Childrens Hospital of Philadelphia Division of Hematology	Philadelphia	Pennsylvania	19104	Recruiting
Washington Institute for Coagulation	Seattle	Washington	98101	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05568719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 27, 2026 · Synced Apr 29, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05568719 live on ClinicalTrials.gov.

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