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

Plain-language summary

This study follows the long-term safety and effect of the gene therapies giroctocogene fitelparvovec or fidanacogene elaparvovec in people who previously received them for hemophilia A or B (a bleeding disorder) in earlier Pfizer-sponsored studies, and examines how the AAV vector integrates in the liver. Only people who took part in the specified earlier Pfizer studies are included. The study is in Phase 3 and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Pfizer

Intervention

Testing of hepatic AAV Vector integration

Start date

12/28/2022

Estimated completion

2/25/2040

Countries

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

Related genes

Locations

• Rancho Cordova, United States
• Sacramento, United States
• Sacramento, United States
• Sacramento, United States
• Sacramento, United States
• San Francisco, United States
• Tampa, United States
• Tampa, United States
• Madison, United States
• New York, United States
• New York, United States
• Philadelphia, United States
• Philadelphia, United States
• Seattle, United States
• Camperdown, Australia
• Camperdown, Australia
• Toronto, Canada
• Seoul, South Korea
• Malmö, Sweden
• Taichung, Taiwan
• Taipei, Taiwan
• Izmir, Turkey (Türkiye)
• Adana, Turkey (Türkiye)

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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