A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
Launched by BAXALTA NOW PART OF SHIRE · Nov 7, 2019
Trial Information
Current as of July 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the long-term effects of a medication called ADYNOVI/ADYNOVATE in people with Hemophilia A, a condition that affects blood clotting. The main goal of the study is to see if there are any side effects when this treatment is used in everyday medical practice over an extended period. This trial is currently active, but it's not recruiting new participants.
To be eligible for the study, participants must be diagnosed with Hemophilia A and prescribed ADYNOVI/ADYNOVATE for treatment. They should also have a negative test for factor VIII inhibitors, which are substances that can interfere with treatment. Anyone interested in joining must give their consent, and it’s important that they can understand and communicate about their participation. If you or a loved one qualifies, you can expect to receive the medication as part of your regular treatment while also helping researchers gather important information about its long-term safety and effectiveness.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
- • Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
- • Negative factor VIII (FVIII) inhibitor test at study entry.
- • Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.
- • Exclusion Criteria
- • Previous participation in this study. Participation is defined as signed informed consent.
- • Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
- • Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
About Baxalta Now Part Of Shire
Baxalta, now part of Shire, is a global biopharmaceutical company dedicated to developing innovative therapies for rare and complex diseases. With a strong emphasis on patient-centric solutions, Baxalta leverages cutting-edge science and advanced technologies to address unmet medical needs, particularly in hematology, immunology, and oncology. The company is committed to advancing clinical research and fostering collaborations that enhance treatment options and improve quality of life for patients worldwide. As part of Shire, Baxalta continues to build on a legacy of excellence in biopharmaceutical development, driving forward the next generation of therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Taipei, , Taiwan
Bangkok, , Thailand
Berlin, , Germany
Taipei, , Taiwan
Barcelona, , Spain
Bangkok, , Thailand
Milano, , Italy
Pecs, , Hungary
Seoul, , Korea, Republic Of
Gainesville, Florida, United States
Praha 5, , Czechia
Zagreb, , Croatia
Chiang Mai, , Thailand
Göteborg, , Sweden
Malaga, , Spain
Pecs, , Hungary
Göteborg, , Sweden
Taoyuan, , Taiwan
Sofia, , Bulgaria
Debrecen, , Hungary
Budapest, , Hungary
Zagreb, , Croatia
Ulsan, , Korea, Republic Of
Nyiregyhaza, , Hungary
Seoul, , Korea, Republic Of
Mohacs, , Hungary
Palma De Mallorca, Baleares, Spain
Torino, , Italy
Bonn, , Germany
Hannover, , Germany
Roma, , Italy
Las Palmas, , Spain
Usti Nad Labem, , Czechia
Baden Wuerttemberg, , Germany
Budapest, , Hungary
Baleares, , Spain
Heidelberg, Baden Wuerttemberg, Germany
Roma, , Italy
Groningen, , Netherlands
Taipei, , Taiwan
Bangkoknoi Bangkok, , Thailand
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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