Evaluating the safety and effectiveness of gene therapies for Hemophilia A and B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the long-term safety and efficacy of two gene therapies, giroctocogene fitelparvovec for Hemophilia A and fidanacogene elaparvovec for Hemophilia B, in patients who have previously participated in Pfizer-sponsored clinical trials. Participants will undergo regular assessments based on standard care protocols to monitor their health outcomes. The study aims to gather data on the integration of the adeno-associated virus vector in the liver and its impact on bleeding episodes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

-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.

Exclusion Criteria:

-None

Where it's running

• The Regents of the University of California||UC Davis Health
  Rancho Cordova, California, United States Recruiting
• UC Davis Health
  Sacramento, California, United States Recruiting
• UC Davis Ambulatory Care Clinic
  Sacramento, California, United States Recruiting
• UC Davis Hemophilia Treatment Center
  Sacramento, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• UCSF Outpatient Hematology Clinic
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SR604: a new treatment tested in adults with Hemophilia A/B or congenital Factor VII deficiency

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• ATHNdataset registry for people with bleeding and clotting disorders

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• Is synovial proliferation in haemophilia joints active or inactive?

  This project will test whether ultrasound, MRI and elastography can tell if subclinical synovial proliferation in people with severe haemophilia is currently active so clinicians can treat earlier.

  Recruiting UMC Utrecht · Utrecht · NCT06809972

• Observational study of blood clotting and bleeding disorders in Chinese patients

  This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality and 4 other locations · NCT06727669

• Evaluating the safety and effects of SR604 in healthy individuals and those with Hemophilia A or B

  This study is testing a new drug called SR604 to see if it's safe and effective for healthy people and those with Hemophilia A or B.

  Recruiting at 8 sites Phase 1 Equilibra Bioscience LLC · Glendale, California and 9 other locations · NCT06349473

• Non-invasive prenatal diagnosis for single gene disorders

  This study is testing a new way to safely diagnose single-gene disorders in unborn babies using a simple blood test from the mother, starting as early as 9 weeks into the pregnancy.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT06147414

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.