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 |
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.
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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Miami Children's Hospital Welcome to Miami Children
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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