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Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC) (EPIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Mast Therapeutics, Inc.
Information provided by (Responsible Party):
Mast Therapeutics, Inc. Identifier:
First received: November 27, 2012
Last updated: January 9, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Vaso-occlusive Crisis
Sickle Cell Disease
Drug: Saline
Drug: MST-188
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Mast Therapeutics, Inc.:

Primary Outcome Measures:
  • Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease. [ Time Frame: Study participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-hospitalization rate for VOC [ Time Frame: Hospital discharge to 14 days post-discharge ] [ Designated as safety issue: No ]
  • Occurence of acute chest syndrome [ Time Frame: Randomization to 120 hours after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 388
Study Start Date: May 2013
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: MST-188
Other Name: vepoloxamer
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
Drug: Saline


Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01737814

Contact: Mast Therapeutics Call Center 1-888-965-1238

  Hide Study Locations
United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36688
Contact: A Siddiqui    251-405-5172      
Contact: Shinekia Dillon   
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Erica Olson   
United States, California
UCSF Benioff Children's Hospital Recruiting
Oakland, California, United States, 94609
Contact: Deanna Fink   
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Contact: Majid Mirmiran   
Rady Children's Hosptial Recruiting
San Diego, California, United States, 92123
Contact: Theresa Vella   
Harbor-UCLA Medical Center Recruiting
Torrence, California, United States, 90502
Contact: Helen Todoroki    310-222-4156   
United States, Delaware
Al DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Lynn Marrs   
United States, District of Columbia
Howard University Recruiting
Washington, District of Columbia, United States, 20060
United States, Florida
Children's Hospital of SouthWest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Molly Arnstrom   
Joe Dimaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Paulette Smith   
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Vanessa Cumming    305-243-9431   
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Fabian Castillo    786-662-4146   
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Laurie Barrett   
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Fife    813-844-7829   
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Neli Stoyanova   
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Betty Pace, MD    706-721-0174   
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Jaclyn Janoski    312-227-4825   
Children's Hospital at the University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Lani Krauz   
United States, Indiana
Fort Wayne Lutheran Hospital Recruiting
Ft. Wayne, Indiana, United States, 46804
Contact: Shelley Ramsey    260-435-2501   
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anne Bubnick   
United States, Iowa
University of Iowa-Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Natalie Kamberos, MD    319-384-5280      
United States, Kentucky
University of Louisville/Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jennifer Comings   
United States, Louisiana
Our Lady of the Lake Children's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Christine LeBoeuf   
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Angela Lala   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Paul Kamate   
The Herman and Walter Samuelson Children's Hospital at Sinai Recruiting
Baltimore, Maryland, United States, 21215
Contact: Stephanie Entrup   
United States, Michigan
Children's Hospital of Michigan-Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Theresa Spranger   
Hurley Research Center Recruiting
Flint, Michigan, United States, 48503
Contact: Jenny LaChance   
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Stefanie Pepper    601-815-9185   
United States, New Jersey
Rutger's University Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Julianne Wilson   
United States, New York
Bronx Lebanon Hospital Recruiting
Bronx, New York, United States, 10457
Contact: Grace Malonga   
NY Methodist Recruiting
Brooklyn, New York, United States, 11215
Contact: Carolyn Payne    718-780-5282   
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Antonella Farrell   
Golisano Children's Hospital at URMC Recruiting
Rochester, New York, United States, 14642
Contact: S Noronha, MD    585-273-3159      
Contact: Cate Olin    585-273-3159   
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David Gerard Wichlan   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Sonja Hunter   
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Ashley Allsbrook       ALLSBROOKA@ECU.EDU   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Eileen Beckman   
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Catherine Tasi   
United States, Oregon
Randall Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Martha Raschko    503-276-9376   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ashley Woodford   
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Angela Martino    412-692-6467   
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Jude Jonassaint   
United States, South Carolina
The Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lisa Kuisel   
United States, Tennessee
T.C. Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Peggy Green    423-778-7024   
United States, Texas
Cook's Children Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: Renna John   
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Bogdan Dinu   
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottsville, Virginia, United States, 22908
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Sabrina Wigginton   
Children's Hospital of Richmond Recruiting
Richmond, Virginia, United States, 23298
Contact: India Sisler    804-628-0212      
Reearch Center Recruiting
Antwerp, Belgium
Research Center Recruiting
Brussels, Belgium
Research Center Recruiting
Edgem, Belgium
Research Center Recruiting
Liege, Belgium
Research Center Recruiting
Montegnee, Belgium
Resaerch Center Recruiting
Rio de Janerio, Brazil
Research Center Recruiting
Sao Paulo, Brazil
Dominican Republic
Research Center Recruiting
Santo Domingo, Dominican Republic, 10101
Research Center Recruiting
Santo Domingo, Dominican Republic, 10514
Research Center Recruiting
Kingston, Jamaica
Research Center Recruiting
Irbid, Jordan
Research Center Recruiting
Beirut, Lebanon
Research Center Recruiting
Tripoli, Lebanon
Research Center - Child Health Department Recruiting
Muscat, Oman
Research Center Recruiting
Muscat, Oman
Research Center Hospital del Nino Recruiting
Panama, Panama
Research Center Hospital of Pediatric Specialities Recruiting
Panama, Panama
Research Center Metropolitan Hospital Recruiting
Panama, Panama
Research Center Recruiting
Madrid, Spain
Research Center Recruiting
Adana, Turkey
Research Center Recruiting
Istanbul, Turkey
Research Center Recruiting
Mersin, Turkey
Sponsors and Collaborators
Mast Therapeutics, Inc.
Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.
  More Information

Responsible Party: Mast Therapeutics, Inc. Identifier: NCT01737814     History of Changes
Other Study ID Numbers: MST-188-01 
Study First Received: November 27, 2012
Last Updated: January 9, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Committee of Ethics in Research
Dominican Republic: Consejo Nacional de Bioetica en Salud
Jordan: Jordanian Food and Drug Administration
Lebanon: Institutional Review Board
Oman: Academic Accreditation Authority
Panama: Ministry of Health
Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Saudi Arabia: Saudi Food and Drug Administration
Turkey: Drug and Medical Device Institution
Jamaica: Ministry of Health

Keywords provided by Mast Therapeutics, Inc.:
sickle cell disease
vaso-occlusive crisis

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn processed this record on October 20, 2016