Evaluation of Repeat Administration of Purified Poloxamer 188 (EPIC-E)

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • United States
    • California
      • San Diego, California, United States
        • Rady Children's Hospital
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Children's Hospital of Southwest Florida
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
    • Illinois
      • Chicago, Illinois, United States
        • Ann and Robert H. Lurie Children's Hospital of Chicago
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa Children's Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Children's Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Rutgers University
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States
        • T. C. Thompson Children's Hospital

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as measured as the incidence of adverse events
Time Frame: 30 days after administration of study drug
30 days after administration of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of re-hospitalization for recurrence of VOC
Time Frame: Within 14 days of the date of discharge
Within 14 days of the date of discharge
Occurrence of acute chest syndrome
Time Frame: Within 120 hours of registration
Within 120 hours of registration

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.

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

June 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 20, 2015

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-188-04

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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