Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
- Conditions
- Vaso-occlusive CrisisSickle Cell Disease
- Interventions
- Drug: Saline
- Registration Number
- NCT01737814
- Lead Sponsor
- Mast Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MST-188 MST-188 MST-188 injection administered as a continuous infusion 100 mg/kg for 1 hour followed by 30 mg/kg/hr for up to 48 hours. Saline Saline Saline administered as a continuous infusion for up to 49 hours
- Primary Outcome Measures
Name Time Method Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease. Study participants will be followed for the duration of hospital stay, an expected average of 4 days
- Secondary Outcome Measures
Name Time Method Re-hospitalization rate for VOC Hospital discharge to 14 days post-discharge Occurence of acute chest syndrome Randomization to 120 hours after randomization
Trial Locations
- Locations (57)
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Children's Hospital at the University of Illinois
🇺🇸Chicago, Illinois, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
The Herman and Walter Samuelson Children's Hospital at Sinai
🇺🇸Baltimore, Maryland, United States
University of Miami
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
NY Methodist
🇺🇸Brooklyn, New York, United States
Children's Hospital of Michigan-Wayne State University
🇺🇸Detroit, Michigan, United States
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
University of Virginia Medical Center
🇺🇸Charlottsville, Virginia, United States
Golisano Children's Hospital at URMC
🇺🇸Rochester, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cook's Children Hospital
🇺🇸Fort Worth, Texas, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Research Center
🇹🇷Mersin, Turkey
Bronx Lebanon Hospital
🇺🇸Bronx, New York, United States
Resaerch Center
🇧🇷Rio de Janerio, Brazil
Research Center - Child Health Department
🇴🇲Muscat, Oman
University of South Alabama
🇺🇸Mobile, Alabama, United States
Rady Children's Hosptial
🇺🇸San Diego, California, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
UCSF Benioff Children's Hospital
🇺🇸Oakland, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrence, California, United States
Children's Hospital of SouthWest Florida
🇺🇸Fort Myers, Florida, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Fort Wayne Lutheran Hospital
🇺🇸Ft. Wayne, Indiana, United States
University of Iowa-Children's Hospital
🇺🇸Iowa City, Iowa, United States
Our Lady of the Lake Children's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Rutger's University
🇺🇸New Brunswick, New Jersey, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Al DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Joe Dimaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Hurley Research Center
🇺🇸Flint, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
T.C. Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Children's Hospital of Richmond
🇺🇸Richmond, Virginia, United States
Reearch Center
🇧🇪Antwerp, Belgium
Research Center Hospital del Nino
🇵🇦Panama, Panama
Research Center Hospital of Pediatric Specialities
🇵🇦Panama, Panama
Research Center Metropolitan Hospital
🇵🇦Panama, Panama
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of North Carolina-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Louisville/Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Randall Children's Hospital
🇺🇸Portland, Oregon, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of California Davis Health System
🇺🇸Sacramento, California, United States