Phase III with ALX0681 in Acquired Thrombotic Thrombocytopenic Purpura
Research type
Research Study
Full title
A Phase III Double-Blind, Randomized, Parallel Group, Multicenter Placebo-Controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura
IRAS ID
186018
Contact name
Marie Scully
Contact email
Sponsor organisation
Ablynx NV
Eudract number
2015-001098-42
Clinicaltrials.gov Identifier
Clinical Research Network, 4790
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The aim of the study is to evaluate the efficacy and safety of the study drug in comparison to placebo (similar to study drug without the active component) in rapidly reducing the formation of clots in blood vessels and restoring platelet level to normal in subjects with acquired thrombotic thrombocytopenic purpura (TTP), and who have received standard of care treatment (plasma exchange and immunosuppresive medication). The efficacy of the study drug on tissue and organ damage will be also assessed. The treatment consists of a daily administration of the study drug or placebo for 5 days with standard of care treatment at the hospital and then for at least 30 days at home. The study could last from 2 months up to maximum of 6 months according to the participant’s response to treatment. In total, there will be 92 subjects participating in this study around the world including approximately 10 from the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1441
Date of REC Opinion
15 Oct 2015
REC opinion
Further Information Favourable Opinion