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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mast Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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