242HA201: Prospective Study in Subjects With Severe Hemophilia A
Research type
Research Study
Full title
A Prospective Study in Subjects With Severe Hemophilia A Who are Currently Receiving a Marketed FVIII Therapy
IRAS ID
248644
Contact name
Charles Hay
Contact email
Sponsor organisation
Bioverativ Therapeutics Inc.
Duration of Study in the UK
1 years, 5 months, 21 days
Research summary
The purpose of this research study is to collect data regarding bleeding episodes and treatment information in patients with severe haemophilia A. The study also will collect information on the use of marketed FVIII product (which is being made by the sponsor), the joint health of patients with severe haemophilia A and determine the impact of the disease on the quality of life among the patients.
This study is a research study and there is no study medication or therapy that will be given to the study participants.
Bioverative Therapeutics Inc. is the sponsor for this study based in the United States. Approximately 150 men and women, aged 12 years or older, will take part in this research at approximately 50 sites worldwide.
The participants’ involvement will last a maximum of 12 months and will consist of the enrolment of patients who meet the eligibility criteria and their observation throughout participation in the study.
In addition to the study visits, the participants may have additional visits to the study site as part of their usual care for haemophilia A or if the study doctor feels it is necessary for their health.
The data collected for this study may be used by the participants in a subsequent Bioverative-sponsored interventional study.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0627
Date of REC Opinion
7 Nov 2018
REC opinion
Favourable Opinion