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

NCT05568719 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2040-02-25
Completion
2040-02-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568719 on ClinicalTrials.gov