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

Part of paid clinical trials in Rancho Cordova, California.

Sponsor
Pfizer
Study ID
NCT05568719
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hemophilia A
  • Hemophilia B

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testing of hepatic AAV Vector integration — DIAGNOSTIC_TEST
    Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated

Study Details

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.

Key Dates

Start date
Dec 28, 2022
Status verified
May 2026
Primary completion
Feb 25, 2040
Completion
Feb 25, 2040

Study Design

Enrollment
173 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Hemophilia A / giroctocogene fitelparvovec
    Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study
  • Other: Hemophilia B / fidanacogene elaparvovec
    Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study

Primary Outcome Measure

Incidence of thromboembolic events [ Time Frame: Day 1 to 10 years ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
The Regents of the University of California||UC Davis HealthRancho CordovaCalifornia95670-
UC Davis Ambulatory Care ClinicSacramentoCalifornia95817-
UC Davis HealthSacramentoCalifornia95816-
UC Davis Hemophilia Treatment CenterSacramentoCalifornia95817-
UC Davis Medical CenterSacramentoCalifornia95817-
UCSF Outpatient Hematology ClinicSan FranciscoCalifornia94143-
The University of South Florida Board of TrusteesTampaFlorida33620-
USF Health Morsani Center For Advanced HealthcareTampaFlorida33612-
Mississippi Center For Advanced MedicineMadisonMississippi39110-
Cornell University||Joan & Sanford I. Weill Medical CollegeNew YorkNew York10065-
Weill Cornell Medical College-New York Presbyterian HospitalNew YorkNew York10065-
The Childrens Hospital of Philadelphia Division of HematologyPhiladelphiaPennsylvania19104-
The Childrens Hospital of Philadelphia Division of HematologyPhiladelphiaPennsylvania19146-
Washington Institute for CoagulationSeattleWashington98101-

Find similar trials in Rancho Cordova, CA

By research site
The Regents of the University of California||UC Davis Health· Rancho Cordova, CAUC Davis Ambulatory Care Clinic· Sacramento, CAUC Davis Health· Sacramento, CAUC Davis Hemophilia Treatment Center· Sacramento, CAUC Davis Medical Center· Sacramento, CAUCSF Outpatient Hematology Clinic· San Francisco, CA

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