Trial intelligence / Profile preview

Long-term safety and effectiveness of giroctocogene fitelparvovec and fidanacogene elaparvovec in hemophilia A and B

2025-523660-21-00Phase 3Authorised

Sponsor
Pfizer
Start
Jul 2026
Modality
Recombinant Proteins and Enzymes, Viral Vectors → Gene Addition/Replacement → Gene Therapies, Gene Therapies
Countries
15
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Overview

Phase 3, open-label trial of giroctocogene fitelparvovec and fidanacogene elaparvovec in hemophilia A and hemophilia B (HB) (2 cohorts), sponsored by Pfizer. Primary endpoints: Incidence of thromboembolic events, Incidence of factor inhibitor development and 3 more. Planned start Jul 2026; status: authorised.

02

Drugs

giroctocogene fitelparvovecfidanacogene elaparvovec
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Conditions

hemophilia Ahemophilia B (HB)

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