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โ† Trials
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An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A

Recruitingn/aAges 7 Years - 12 YearsAllBayer
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In plain words

What the trial is, and whether it could suit you

This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to \<12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study. In this study, the data will be collected from participants who are receiving their usual treatment with damoctocog alfa pegol as prescribed by their doctor. These children have previously received damoctocog alfa pegol or other factor 8 (FVIII) products. Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At tim

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of hemophilia A * Patients must be 7 to \< 12 years of age at enrollment * Patients previously treated for hemophilia A ((โ‰ฅ50 exposure days to FVIII) * No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor * Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry * Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year) * Signed informed consent/assent. Exclusion Criteria: * Presence of a FVIII inhibitor * Concurrent participation in an investigational program with interventions outside of routine clinical practice * Diagnosis of any other bleeding/coagulation disorder other than hemophilia A * Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period * Contra-indications according to the local marketing authorization * Current immune tolerance induction (ITI) treatment for a FVIII inhibitor
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What it tests

  • Damoctocog alfa pegol (Jivi, Bay94-9027)
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Where

12 sites
Loma Linda University Health
Loma Linda, United States
Rutgers, The State University
New Brunswick, United States
Many locations
Many Locations, Brazil
Many locations
Many Locations, Canada
Many locations
Many Locations, Colombia
Many locations
Many Locations, Denmark
Many locations
Many Locations, Italy
Many locations
Many Locations, Japan

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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