Joint Health Study

Completed

Conditions studied: Hemophilia B

In brief

This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% Factor IX (FIX or Factor 9). This study will test the hypothesis that an extended half-life (EHL) FIX product with an intended trough of \>10% could offer better protection than previous treatment concentrates. This study also examines whether or not joint damage could be diagnosed earlier using ultrasound images.

Key facts

Study ID

NCT03358836

Run by

Bloodworks

People needed

8

Starts

2017-11-15

Expected to finish

2020-08-17

Last updated by the study team

2022-06-22

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Severe hemophilia B (FIX <1%)
• Either on demand or on prophylaxis with rFIX or EHL-rIX products with the intention to stay on the current regimen for the next 3 years
• For Group C, start of this treatment regimen up to 6 months prior is permissible

You may not qualify if…

• Other known bleeding disorder
• Other rheumatologic disorder affecting joints
• Other known neuromotor defect (making physical exam difficult)

Where it is running

• Orthopaedic Institute for Children at University of California Los Angeles — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• Tulane University — New Orleans, Louisiana, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Washington Center for Bleeding Disorders at Bloodworks Northwest — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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