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

Sponsor
Mast Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01737814
Collaborator
(none)
388
Enrollment
72
Locations
2
Arms
5.4
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Feb 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Re-hospitalization rate for VOC [Hospital discharge to 14 days post-discharge]

    2. Occurence of acute chest syndrome [Randomization to 120 hours after randomization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mobile Alabama United States 36688
    2 Phoenix Children's Hospital Phoenix Arizona United States 85016
    3 UCSF Benioff Children's Hospital Oakland California United States 94609
    4 University of California Davis Health System Sacramento California United States 95817
    5 Rady Children's Hosptial San Diego California United States 92123
    6 Harbor-UCLA Medical Center Torrence California United States 90502
    7 Al DuPont Hospital for Children Wilmington Delaware United States 19803
    8 Howard University Washington District of Columbia United States 20060
    9 Children's Hospital of SouthWest Florida Fort Myers Florida United States 33908
    10 Joe Dimaggio Children's Hospital Hollywood Florida United States 33021
    11 University of Miami Miami Florida United States 33136
    12 Miami Children's Hospital Miami Florida United States 33155
    13 All Children's Hospital St. Petersburg Florida United States 33701
    14 Tampa General Hospital Tampa Florida United States 33606
    15 Grady Memorial Hospital Atlanta Georgia United States 30303
    16 Georgia Regents University Augusta Georgia United States 30912
    17 Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
    18 Children's Hospital at the University of Illinois Chicago Illinois United States 60612
    19 Fort Wayne Lutheran Hospital Ft. Wayne Indiana United States 46804
    20 Riley Hospital for Children Indianapolis Indiana United States 46202
    21 University of Iowa-Children's Hospital Iowa City Iowa United States 52242
    22 University of Louisville/Kosair Children's Hospital Louisville Kentucky United States 40202
    23 Our Lady of the Lake Children's Hospital Baton Rouge Louisiana United States 70808
    24 Children's Hospital of New Orleans New Orleans Louisiana United States 70118
    25 Johns Hopkins Baltimore Maryland United States 21205
    26 The Herman and Walter Samuelson Children's Hospital at Sinai Baltimore Maryland United States 21215
    27 Children's Hospital of Michigan-Wayne State University Detroit Michigan United States 48201
    28 Hurley Research Center Flint Michigan United States 48503
    29 University of Mississippi Medical Center Jackson Mississippi United States 39216
    30 Rutger's University New Brunswick New Jersey United States 08903
    31 Bronx Lebanon Hospital Bronx New York United States 10457
    32 NY Methodist Brooklyn New York United States 11215
    33 Cohen Children's Medical Center New Hyde Park New York United States 11040
    34 Golisano Children's Hospital at URMC Rochester New York United States 14642
    35 University of North Carolina-Chapel Hill Chapel Hill North Carolina United States 27599
    36 Duke University Medical Center Durham North Carolina United States 27710
    37 East Carolina University Greenville North Carolina United States 27834
    38 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    39 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106
    40 Randall Children's Hospital Portland Oregon United States 97227
    41 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    42 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    43 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    44 The Medical University of South Carolina Charleston South Carolina United States 29425
    45 T.C. Thompson Children's Hospital Chattanooga Tennessee United States 37403
    46 Cook's Children Hospital Fort Worth Texas United States 76104
    47 Texas Children's Hospital Houston Texas United States 77030
    48 University of Virginia Medical Center Charlottsville Virginia United States 22908
    49 Children's Hospital of the King's Daughters Norfolk Virginia United States 23507
    50 Children's Hospital of Richmond Richmond Virginia United States 23298
    51 Reearch Center Antwerp Belgium
    52 Research Center Brussels Belgium
    53 Research Center Edgem Belgium
    54 Research Center Liege Belgium
    55 Research Center Montegnee Belgium
    56 Resaerch Center Rio de Janerio Brazil
    57 Research Center Sao Paulo Brazil
    58 Research Center Santo Domingo Dominican Republic 10101
    59 Research Center Santo Domingo Dominican Republic 10514
    60 Research Center Kingston Jamaica
    61 Research Center Irbid Jordan
    62 Research Center Beirut Lebanon
    63 Research Center Tripoli Lebanon
    64 Research Center - Child Health Department Muscat Oman
    65 Research Center Muscat Oman
    66 Research Center Hospital del Nino Panama Panama
    67 Research Center Hospital of Pediatric Specialities Panama Panama
    68 Research Center Metropolitan Hospital Panama Panama
    69 Research Center Madrid Spain
    70 Research Center Adana Turkey
    71 Research Center Istanbul Turkey
    72 Research Center Mersin Turkey

    Sponsors and Collaborators

    • Mast Therapeutics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mast Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01737814
    Other Study ID Numbers:
    • MST-188-01
    First Posted:
    Nov 30, 2012
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Mast Therapeutics, Inc.
    sickle cell disease
    vaso-occlusive crisis
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Oct 28, 2016