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

October 26, 2016 updated by: Mast Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • vepoloxamer
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Study participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Re-hospitalization rate for VOC
Time Frame: Hospital discharge to 14 days post-discharge
Hospital discharge to 14 days post-discharge
Occurence of acute chest syndrome
Time Frame: Randomization to 120 hours after randomization
Randomization to 120 hours after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Investigators

  • Study Director: Edwin L. Parsley, D.O., Mast Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST-188-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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