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EPIC-E: Evaluation of Repeat Administration of Purified Poloxamer 188

Sponsor
Mast Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02449616
Collaborator
(none)
16
Enrollment
9
Locations
1
Arm
1.8
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Repeat Administration of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC-E): An Open-Label Safety Extension Trial Assessing Repeat Administration of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Drug

MST-188

Drug: MST-188
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Other Names:
  • vepoloxamer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety as measured as the incidence of adverse events [30 days after administration of study drug]

    Secondary Outcome Measures

    1. Rate of re-hospitalization for recurrence of VOC [Within 14 days of the date of discharge]

    2. Occurrence of acute chest syndrome [Within 120 hours of registration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Completed participation in study MST-188-01 (EPIC study)

    • Subject age 4 through 65 years

    • Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid 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

    • Subject has been transfused within the past 14 days

    • Subject has complications related to SCD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rady Children's Hospital San Diego California United States
    2 Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    3 Joe Dimaggio Children's Hospital Hollywood Florida United States 33021
    4 Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States
    5 University of Iowa Children's Hospital Iowa City Iowa United States
    6 Our Lady of the Lake Children's Hospital Baton Rouge Louisiana United States 70808
    7 Rutgers University New Brunswick New Jersey United States
    8 Medical University of South Carolina Charleston South Carolina United States
    9 T. C. Thompson Children's Hospital Chattanooga Tennessee United States

    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:
    NCT02449616
    Other Study ID Numbers:
    • MST-188-04
    First Posted:
    May 20, 2015
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Mast Therapeutics, Inc.
    Sickle cell
    vaso-occlusive crisis
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Oct 28, 2016