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

Mast Therapeutics

Status and phase

Completed

Phase 3

Conditions

Vaso-occlusive Crisis

Sickle Cell Disease

Treatments

Drug: Saline

Drug: MST-188

Study type

Interventional

Funder types

Industry

Identifiers

NCT01737814

MST-188-01

Details and patient eligibility

About

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.

Enrollment

388 patients

Sex

All

Ages

4 to 65 years old

Volunteers

No Healthy Volunteers

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