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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Hemophilia B; Hemophilia A

Treatments: Diagnostic Test: Testing of hepatic AAV Vector integration

Study type: Interventional

Funder types: Industry

Identifiers

NCT05568719

C0371017

Details and patient eligibility

About

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.

Enrollment: 263 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

Hemophilia A / giroctocogene fitelparvovec

Other group

Description:

Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study

Treatment:

Diagnostic Test: Testing of hepatic AAV Vector integration

Hemophilia B / fidanacogene elaparvovec

Other group

Description:

Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study

Treatment:

Diagnostic Test: Testing of hepatic AAV Vector integration