Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A
Launched by LUND UNIVERSITY · Apr 11, 2019
Trial Information
Current as of September 07, 2025
Completed
Keywords
ClinConnect Summary
As detailed in brief summary patients will, after accurate information verbally and written according to ethics approval, report bleeding events during previous 6 months. Blood samples are taken, FVIII analyzed (Advate patients) and the individual PK curve determined using MyPKFit. The curve will be discussed together with the patient and levels related to bleed events determined. If needed dose adjustment is done based on the curve. After a further 6 month follow-up bleeds will again be evaluated as well as factor consumption. In this way a better personalized treatment based on PK and cli...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Children and adults with severe hemophilia A (FVIII:C \<1 %), being treated with Advate for more than 50 exposure days (EDs
- Exclusion Criteria:
- • Current evidence of inhibitor as measured by the Nijmegen-modified Bethesda assay
- • Use of another investigational FVIII product in the previous month
About Lund University
Lund University, a prestigious research institution in Sweden, is renowned for its commitment to advancing scientific knowledge and innovation in healthcare. With a strong emphasis on interdisciplinary collaboration, the university conducts cutting-edge clinical trials aimed at addressing critical health challenges. Leveraging its state-of-the-art facilities and a diverse network of expert researchers, Lund University strives to translate research findings into effective therapeutic solutions, ultimately improving patient outcomes and enhancing public health. Through its dedication to ethical research practices and patient safety, Lund University plays a pivotal role in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Malmo, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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