Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:4 - 65
Updated:4/21/2016
Start Date:May 2013
Contact:Mast Therapeutics CT.gov Call Center
Phone:1-888-965-1238

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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

The purpose of this study is to evaluate whether MST-188 can reduce the duration of
vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also
evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a
recurrence of VOC. Additionally, this study will compare the development of acute chest
syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.


Inclusion Criteria:

- Age 4 through 65 years

- Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal

- Subject is experiencing acute pain typical of vaso-occlusive crisis requiring
treatment with parenteral analgesia

- Subject requires hospitalization

Exclusion Criteria:

- Subject has acute chest syndrome

- Subject's laboratory results indicate inadequate organ function

- Subject is pregnant or nursing an infant

- Subject had a painful crisis requiring hospitalization within the preceding 14 days
or has experienced > 5 hospitalizations for VOC in the prior 6 months

- Subject has been transfused within the past 14 days

- Subject is hospitalized for a condition other than VOC

- Subject has complications related to SCD
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