3-001:Study of ART-123 in Subjects with Severe Sepsis and Coagulopathy
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE–BLIND, PLACEBO–CONTROLLED, PHASE-3 STUDY TO ASSESS THE SAFETY AND EFFICACY OF ART-123 IN SUBJECTS WITH SEVERE SEPSIS AND COAGULOPATHY
IRAS ID
117310
Contact name
Jane Eddleston
Sponsor organisation
Asahi Kasei Pharma America Corporation
Eudract number
2012-002251-42
Clinicaltrials.gov Identifier
Research summary
Despite significant advances over the past several decades, mortality from sepsis remains unacceptably high. The risk of death is related to the severity of the sepsis, which is characterised in terms of the presence of organ dysfunctions and coagulopathy.This randomised, double-blind, placebo??controlled, phase-3 study will assess the safety and efficacy of ART-123 in subjects with severe sepsis and coagulopathy. The study is sponsored by Asahi Kasei Pharma America Corporation. ART-123 is a recombinant soluble human thrombomodulin, which means that it was produced by laboratory genetic manipulation. It acts by causing the blood to not clot and prevents the loss of platelets in the blood.ART-123 has been given to more than 1000 subjects in research studies and is approved for use in Japan for treatment of Disseminated Coagulopathy (DIC). More than 25,000 patients have been treated with ART-123 in Japan. Once subjects are enrolled to the study they will receive either ART-123 or placebo in addition to standard care, for 6 days. They will be monitored for safety through 28 days after the last dose of study drug and contacted at 28 days and 3, 6 and 12 months to assess their health status. About 800 subjects (patients) will be in this study with about 35 subjects being recruited in the UK. The study will take place in up to 240 hospitals around the world.The entire study duration is 12 months, however, subjects who make antibodies to ART-123 will be followed up for an additional 18 months or until their antibody levels return to normal.Study assessments will involve, medical history, physical exams. Vital signs, blood tests and electrocardiograms (ECGs).
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0003
Date of REC Opinion
5 Mar 2013
REC opinion
Further Information Favourable Opinion