RECRUITING

An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

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

This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.

Official Title

An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in Patients With Hemophilia B

Quick Facts

Study Start:2023-06-15
Study Completion:2043-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06008938

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:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Treatment with commercial HEMGENIX.
  2. * Have provided signed written informed consent within 3 months before or within 6 months after HEMGENIX treatment, or within 6 months of when the study is initiated at the participating site.
  3. * Adult patients (≥ 18 years) with hemophilia B who have consented and enrolled in ATHN Transcends Hemophilia Cohort (or a similar registry) and are receiving FIX prophylaxis therapy.
  1. * The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Global Program Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

American Thrombosis and Hemostasis Network
Rochester, New York, 14604
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Global Program Director, STUDY_DIRECTOR, CSL Behring

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 Date2023-06-15
Study Completion Date2043-08

Study Record Updates

Study Start Date2023-06-15
Study Completion Date2043-08

Terms related to this study

Keywords Provided by Researchers

  • Hemophilia B
  • HEMGENIX

Additional Relevant MeSH Terms

  • Hemophilia B