Post Marketing study following long term prophylactic Optivate usage
Research type
Research Study
Full title
Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic Optivate® Treatment in Subjects with Severe Haemophilia A.
IRAS ID
192559
Contact name
Lisa Wilson
Contact email
Sponsor organisation
Bio Products Laboratory
Eudract number
2012-004606-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
This is a post marketing safety study to primarily assess factor VIII inhibitor levels for a minimum of 100 treatment days per patient. The study will also assess the efficacy and tolerability of factor VIII treatment.
Each patient will have 4 factor VIII recovery assessments over a period of approximately 12 months. Each recovery assessement has two main purposes. Firstly, prior to each recovery assessment the patient will have a factor VIII inhibitor test before being infused with Optivate®. This is to help assess the continued safety of Optivate®. Secondly, the recovery assessment will measure the increase in factor VIII concentration in the patient during the first hour following Optivate® infusion. This is to help assess the efficacy and tolerability of Optivate® treatment.REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/0129
Date of REC Opinion
17 Feb 2016
REC opinion
Favourable Opinion