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

  • UC Davis Health not yet accepting patients
    Sacramento California 95816 United States
  • UC Davis Ambulatory Care Clinic not yet accepting patients
    Sacramento California 95817 United States
  • UC Davis Hemophilia Treatment Center not yet accepting patients
    Sacramento California 95817 United States
  • UC Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • UCSF Outpatient Hematology Clinic not yet accepting patients
    San Francisco California 94143 United States
  • Mississippi Center For Advanced Medicine accepting new patients
    Madison Mississippi 39110 United States
  • USF Health Morsani Center For Advanced Healthcare accepting new patients
    Tampa Florida 33612 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05568719
Phase
Phase 3 Hemophilia Research Study
Study Type
Interventional
Participants
Expecting 263 study participants
Last Updated