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A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy

NCT05568459 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2026-03-19

No results posted yet for this study

Summary

This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individual participant while they continue to use their usual FIX replacement therapy. There is no experimental treatment being tested in this study. The study is informational, and part of a larger program to understand and treat Hemophilia B with a potential experimental new therapy in the future. There is no obligation to agree to taking part in this future study.

The study is looking to answer several other research questions to help understand each participant's individual disease characteristics, including:

* How often to use FIX replacement therapy, both on a regular basis (prophylaxis) and as needed to treat bleeding events
* Measurement of FIX activity (factor IX is a clotting factor) by different laboratories using different types of tests in Hemophilia B participants
* Possible complications from the FIX replacement therapy the patient receives (usual standard of care will continue to be used)
* How quality of life is affected by Hemophilia B
* How joint health is affected by Hemophilia B
* How often the participant visits the emergency room, urgent care center, physician's office, hospital, or has a telemedicine visit as a result of bleeding events
* Whether the body makes antibodies (a protein produced by the body's immune system) against the FIX replacement therapy you receive, which could make the drug less effective or could lead to side effects

Conditions

  • Hemophilia B

Interventions

OTHER

Non-Interventional

No study treatment will be administered in this study.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2026-05-21
Completion
2026-05-21

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568459 on ClinicalTrials.gov