Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
NCT ID: NCT01737814
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
MST-188
Saline
Saline administered as a continuous infusion for up to 49 hours
Saline
Interventions
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Saline
MST-188
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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'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
4 Years
65 Years
ALL
No
Sponsors
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Mast Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edwin L. Parsley, D.O.
Role: STUDY_DIRECTOR
Mast Therapeutics, Inc.
Locations
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University of South Alabama
Mobile, Alabama, United States
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
The Herman and Walter Samuelson Children's Hospital at Sinai
Baltimore, Maryland, United States
Children's Hospital of Michigan-Wayne State University
Detroit, Michigan, United States
Hurley Research Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Rutger's University
New Brunswick, New Jersey, United States
NY Methodist
Brooklyn, New York, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
Golisano Children's Hospital at URMC
Rochester, New York, United States
Bronx Lebanon Hospital
The Bronx, New York, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Randall Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States
Cook's Children Hospital
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottsville, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Children's Hospital of Richmond
Richmond, Virginia, United States
Reearch Center
Antwerp, , Belgium
Research Center
Brussels, , Belgium
Research Center
Edgem, , Belgium
Research Center
Liège, , Belgium
Research Center
Montegnée, , Belgium
Resaerch Center
Rio de Janerio, , Brazil
Research Center
São Paulo, , Brazil
Research Center
Santo Domingo, , Dominican Republic
Research Center
Santo Domingo, , Dominican Republic
Research Center
Kingston, , Jamaica
Research Center
Irbid, , Jordan
Research Center
Beirut, , Lebanon
Research Center
Tripoli, , Lebanon
Research Center - Child Health Department
Muscat, , Oman
Research Center
Muscat, , Oman
Research Center Hospital del Nino
Panama City, , Panama
Research Center Hospital of Pediatric Specialities
Panama City, , Panama
Research Center Metropolitan Hospital
Panama City, , Panama
Research Center
Madrid, , Spain
Research Center
Adana, , Turkey (Türkiye)
Research Center
Istanbul, , Turkey (Türkiye)
Research Center
Mersin, , Turkey (Türkiye)
Countries
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References
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Casella JF, Barton BA, Kanter J, Black LV, Majumdar S, Inati A, Wali Y, Drachtman RA, Abboud MR, Kilinc Y, Fuh BR, Al-Khabori MK, Takemoto CM, Salman E, Sarnaik SA, Shah N, Morris CR, Keates-Baleeiro J, Raj A, Alvarez OA, Hsu LL, Thompson AA, Sisler IY, Pace BS, Noronha SA, Lasky JL 3rd, de Julian EC, Godder K, Thornburg CD, Kamberos NL, Nuss R, Marsh AM, Owen WC, Schaefer A, Tebbi CK, Chantrain CF, Cohen DE, Karakas Z, Piccone CM, George A, Fixler JM, Singleton TC, Moulton T, Quinn CT, de Castro Lobo CL, Almomen AM, Goyal-Khemka M, Maes P, Emanuele M, Gorney RT, Padgett CS, Parsley E, Kronsberg SS, Kato GJ, Gladwin MT. Effect of Poloxamer 188 vs Placebo on Painful Vaso-Occlusive Episodes in Children and Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA. 2021 Apr 20;325(15):1513-1523. doi: 10.1001/jama.2021.3414.
Other Identifiers
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MST-188-01
Identifier Type: -
Identifier Source: org_study_id