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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01737814
First received: November 27, 2012
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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 ]

Enrollment: 388
Study Start Date: May 2013
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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01737814

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
UCSF Benioff Children's Hospital
Oakland, California, United States, 94609
University of California Davis Health System
Sacramento, California, United States, 95817
Rady Children's Hosptial
San Diego, California, United States, 92123
Harbor-UCLA Medical Center
Torrence, California, United States, 90502
United States, Delaware
Al DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20060
United States, Florida
Children's Hospital of SouthWest Florida
Fort Myers, Florida, United States, 33908
Joe Dimaggio Children's Hospital
Hollywood, Florida, United States, 33021
University of Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Children's Hospital at the University of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Lutheran Hospital
Ft. Wayne, Indiana, United States, 46804
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa-Children's Hospital
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville/Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, United States, 70808
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
The Herman and Walter Samuelson Children's Hospital at Sinai
Baltimore, Maryland, United States, 21215
United States, Michigan
Children's Hospital of Michigan-Wayne State University
Detroit, Michigan, United States, 48201
Hurley Research Center
Flint, Michigan, United States, 48503
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Rutger's University
New Brunswick, New Jersey, United States, 08903
United States, New York
Bronx Lebanon Hospital
Bronx, New York, United States, 10457
NY Methodist
Brooklyn, New York, United States, 11215
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
Golisano Children's Hospital at URMC
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Oregon
Randall Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
United States, Texas
Cook's Children Hospital
Fort Worth, Texas, United States, 76104
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Medical Center
Charlottsville, Virginia, United States, 22908
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Children's Hospital of Richmond
Richmond, Virginia, United States, 23298
Belgium
Reearch Center
Antwerp, Belgium
Research Center
Brussels, Belgium
Research Center
Edgem, Belgium
Research Center
Liege, Belgium
Research Center
Montegnee, Belgium
Brazil
Resaerch Center
Rio de Janerio, Brazil
Research Center
Sao Paulo, Brazil
Dominican Republic
Research Center
Santo Domingo, Dominican Republic, 10101
Research Center
Santo Domingo, Dominican Republic, 10514
Jamaica
Research Center
Kingston, Jamaica
Jordan
Research Center
Irbid, Jordan
Lebanon
Research Center
Beirut, Lebanon
Research Center
Tripoli, Lebanon
Oman
Research Center - Child Health Department
Muscat, Oman
Research Center
Muscat, Oman
Panama
Research Center Hospital del Nino
Panama, Panama
Research Center Hospital of Pediatric Specialities
Panama, Panama
Research Center Metropolitan Hospital
Panama, Panama
Spain
Research Center
Madrid, Spain
Turkey
Research Center
Adana, Turkey
Research Center
Istanbul, Turkey
Research Center
Mersin, Turkey
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.
  More Information

Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01737814     History of Changes
Other Study ID Numbers: MST-188-01 
Study First Received: November 27, 2012
Last Updated: October 26, 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
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 06, 2016