Not currently recruiting at University of California Health

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

a study on Hemophilia

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

Description

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.

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

Keywords

Hemophilia A, Hemophilia B, bleeding, adeno-associated virus based vector, gene therapy, giroctocogene fitelparvovec, fidanacogene elaparvovec, factor VIII, factor IX, Testing of hepatic AAV Vector integration, Hemophilia A / giroctocogene fitelparvovec, Hemophilia B / fidanacogene elaparvovec

Eligibility

You can join if…

Open to males ages 18 years and up

-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.

You CAN'T join if...

-None

Locations

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT05568719
Phase
Phase 3 Hemophilia Research Study
Study Type
Interventional
Participants
Expecting 263 study participants
Last Updated