Clinical trial

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene…

NCT05568719 · Pfizer, Industry · Recruiting

Key facts

NCT number NCT05568719
Title Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
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
Lead sponsor Pfizer, Industry
Status Recruiting
Phase Phase 3
Study type Interventional
Conditions Hemophilia A, Hemophilia B
Intervention type Diagnostic Test
Interventions Testing of hepatic AAV Vector integration
Enrollment 263
Start date Dec 28, 2022
Primary completion Feb 25, 2040
Completion Feb 25, 2040
First posted Oct 6, 2022
Last update posted Aug 14, 2025
Countries Australia, Turkey (Türkiye), United States

At a glance

  • 10–99 Study sites
  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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