Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
EPIC
1 other identifier
interventional
388
11 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedOctober 28, 2016
October 1, 2016
2.8 years
November 27, 2012
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Re-hospitalization rate for VOC
Hospital discharge to 14 days post-discharge
Occurence of acute chest syndrome
Randomization to 120 hours after randomization
Study Arms (2)
MST-188
EXPERIMENTALMST-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
PLACEBO COMPARATORSaline administered as a continuous infusion for up to 49 hours
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
University of South Alabama
Mobile, Alabama, 36688, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
UCSF Benioff Children's Hospital
Oakland, California, 94609, United States
University of California Davis Health System
Sacramento, California, 95817, United States
Rady Children's Hosptial
San Diego, California, 92123, United States
Harbor-UCLA Medical Center
Torrence, California, 90502, United States
Al DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Children's Hospital of SouthWest Florida
Fort Myers, Florida, 33908, United States
Joe Dimaggio Children's Hospital
Hollywood, Florida, 33021, United States
University of Miami
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Children's Hospital at the University of Illinois
Chicago, Illinois, 60612, United States
Fort Wayne Lutheran Hospital
Fort Wayne, Indiana, 46804, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa-Children's Hospital
Iowa City, Iowa, 52242, United States
University of Louisville/Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, 70808, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118, United States
Johns Hopkins
Baltimore, Maryland, 21205, United States
The Herman and Walter Samuelson Children's Hospital at Sinai
Baltimore, Maryland, 21215, United States
Children's Hospital of Michigan-Wayne State University
Detroit, Michigan, 48201, United States
Hurley Research Center
Flint, Michigan, 48503, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Rutger's University
New Brunswick, New Jersey, 08903, United States
NY Methodist
Brooklyn, New York, 11215, United States
Cohen Children's Medical Center
New Hyde Park, New York, 11040, United States
Golisano Children's Hospital at URMC
Rochester, New York, 14642, United States
Bronx Lebanon Hospital
The Bronx, New York, 10457, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Randall Children's Hospital
Portland, Oregon, 97227, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
Cook's Children Hospital
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottsville, Virginia, 22908, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Children's Hospital of Richmond
Richmond, Virginia, 23298, 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, 10101, Dominican Republic
Research Center
Santo Domingo, 10514, 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)
Related Publications (1)
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.
PMID: 33877274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Edwin L. Parsley, D.O.
Mast Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 30, 2012
Study Start
May 1, 2013
Primary Completion
February 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10