An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A.

Launched by BAYER · Nov 30, 2022

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ClinConnect Summary

The JOIHA study is researching how well a treatment called Jivi works to help prevent joint problems in adults with hemophilia A. Hemophilia A is a condition where the body doesn’t have enough of a protein needed to stop bleeding, which can lead to painful joint bleeding and other complications. In this study, researchers will collect information from adults who are either starting Jivi treatment or who have already been on it for up to a year. They want to see how Jivi, which lasts longer in the body than older treatments, affects joint health over time.

To be eligible for the study, participants must be at least 18 years old and have a confirmed diagnosis of hemophilia A with low levels of the clotting protein. They should have been treated for hemophilia before and will need to have a joint health assessment done before starting Jivi. Throughout the study, participants will not have to attend extra visits or undergo additional tests beyond what is required for their regular care. The researchers will look at the condition of the participants' joints using ultrasound after 24 months of treatment with Jivi and compare it to their status before starting the treatment. This study aims to provide valuable information about how Jivi can help maintain joint health in real-life situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis hemophilia A with FVIII:C ≤2%.
• • Patients ≥ 18 years of age.
• • Previously treated for hemophilia A (PTPs).
• • Patients who had initiated damoctocog alfa pegol maximum 12 months prior to enrollment into the study or who initiate damoctocog alfa pegol treatment at the enrollment , where the decision to initiate damoctocog alfa pegol has been made before the decision for study participation.
• • Patients having a HEAD-US measurement available in the 2 months prior to damoctocog alfa pegol treatment initiation.
• • Patients without previous history of FVIII inhibitors or patients with previous history of FVIII inhibitors on standard prophylaxis therapy for at least 1 year prior to baseline (damoctocog alfa pegol treatment initiation).
• • No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
• • Signed informed consent/assent.
• Exclusion Criteria:
• • Concurrent participation in an investigational program with interventions outside of routine clinical practice.
• • Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
• • Patient on immune tolerance induction (ITI) treatment at the time of enrollment.