Evaluation of Purified Poloxamer 188 in Subjects in Crisis (EPIC)
Research type
Research Study
Full title
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial of MST-188 (purified poloxamer 188) Injection in Subjects with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis
IRAS ID
187217
Contact name
Baba Inusa
Contact email
Sponsor organisation
Mast Therapeutics, Inc.
Eudract number
2013-002986-21
Clinicaltrials.gov Identifier
Research summary
The name of the study drug is “MST-188.” MST-188 is an aqueous solution, administered intravenously shortly after a vaso-occlusive crisis (“VOC” or “pain crisis”) has started. MST-188 has been investigated in seven clinical studies, including four studies in patients with SCD and three studies in healthy volunteers. The purpose of this research study is to learn if MST-188 can decrease the amount of time patients with sickle cell disease experience a VOC. This randomized study drug may decrease the length of time of pain crisis by increasing blood flow to tissue in the body.
Patients will participate in the study for the duration of the hospitalization and for up to 30 days after being discharged from the hospital. Patients will also receive the usual treatment for their VOC during the hospitalization. This treatment may include pain medications and IV fluids. Included in the participation in the study are assessments and exams to evaluate the patient’s VOC. Some of the visits and examinations are part of the normal care provided in the hospital, while others are offered by the study.
The study has four phases: the screening phase, the treatment phase, the post-treatment phase, and the follow-up phase. The screening phase will last from the time the consent form is signed until the time that the study infusion is started. The treatment phase will be while the patient is hospitalized and receiving MST-188 or placebo as an IV for up to 49 hours. The post-treatment phase will start at the end of the treatment phase and will end when patient is discharged from the hospital. The follow-up period will begin at the time of hospital discharge and will continue for 30 days.
About 25 research study participants will be enrolled in the United Kingdom.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/2010
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion