Observational study on how Jivi helps adults with Hemophilia A
Long-term Treatment Outcome of Jivi® Prophylaxis on Joint Health in Adult Patients With Hemophilia A
This study looks at how well Jivi helps adults with Hemophilia A keep their joints healthy and avoid bleeding problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT05643560 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from adults with Hemophilia A who choose to take Jivi, a treatment that replaces the missing clotting factor VIII to prevent bleeding. The study aims to understand the effectiveness of Jivi in maintaining joint health and preventing bleeding complications. Participants are monitored for their experiences and outcomes related to joint health while on Jivi treatment. The study does not involve any specific interventions or changes to the participants' treatment plans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Hemophilia A who have initiated treatment with Jivi within the last 12 months.
Not a fit: Patients who are not diagnosed with Hemophilia A or those who have not initiated treatment with Jivi will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Jivi in preventing joint problems in adults with Hemophilia A.
How similar studies have performed: Other observational studies have shown positive outcomes with similar treatments for Hemophilia A, suggesting that this approach may yield beneficial insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Multiple Locations
- Many Locations — Multiple Locations, Italy (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.