Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
Completed · Phase 3
Conditions studied: Vaso-occlusive Crisis, Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT01737814
- Run by
- Mast Therapeutics, Inc.
- People needed
- 388
- Starts
- 2013-05-01
- Last updated by the study team
- 2016-10-28
Who can join
Age: 4 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- UCSF Benioff Children's Hospital — Oakland, California, United States
- University of California Davis Health System — Sacramento, California, United States
- Rady Children's Hosptial — San Diego, California, United States
- Harbor-UCLA Medical Center — Torrence, California, United States
- Al DuPont Hospital for Children — Wilmington, Delaware, United States
- Howard University — Washington D.C., District of Columbia, United States
- Children's Hospital of SouthWest Florida — Fort Myers, Florida, United States
- Joe Dimaggio Children's Hospital — Hollywood, Florida, United States
- University of Miami — Miami, Florida, United States
- Miami Children's Hospital — Miami, Florida, United States
- All Children's Hospital — St. Petersburg, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Grady Memorial Hospital — Atlanta, Georgia, United States
- Georgia Regents University — Augusta, Georgia, United States
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Children's Hospital at the University of Illinois — Chicago, Illinois, United States
- Fort Wayne Lutheran Hospital — Fort Wayne, Indiana, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- University of Iowa-Children's Hospital — Iowa City, Iowa, United States
- University of Louisville/Kosair Children's Hospital — Louisville, Kentucky, United States
- Our Lady of the Lake Children's Hospital — Baton Rouge, Louisiana, United States
- Children's Hospital of New Orleans — New Orleans, Louisiana, United States
- Johns Hopkins — Baltimore, Maryland, United States
- University of South Alabama — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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