RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-12-28
Study Completion:2039-09-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05568719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

UC Davis Health
Sacramento, California, 95816
United States
UC Davis Ambulatory Care Clinic
Sacramento, California, 95817
United States
UC Davis Hemophilia Treatment Center
Sacramento, California, 95817
United States
UC Davis Medical Center
Sacramento, California, 95817
United States
UCSF Outpatient Hematology Clinic
San Francisco, California, 94143
United States
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, 33612
United States
Mississippi Center For Advanced Medicine
Madison, Mississippi, 39110
United States
The Childrens Hospital of Philadelphia Division of Hematology
Philadelphia, Pennsylvania, 19104
United States
Washington Institute for Coagulation
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-28
Study Completion Date2039-09-03

Study Record Updates

Study Start Date2022-12-28
Study Completion Date2039-09-03

Terms related to this study

Keywords Provided by Researchers

  • bleeding
  • adeno-associated virus based vector
  • gene therapy
  • giroctocogene fitelparvovec
  • fidanacogene elaparvovec
  • factor VIII
  • factor IX

Additional Relevant MeSH Terms

  • Hemophilia A
  • Hemophilia B