Back to resultsEvaluation of Repeat Administration of Purified Poloxamer 188 (EPIC-E)
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MST-188
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle cell, vaso-occlusive crisis
Eligibility Criteria
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
Sites / Locations
- Rady Children's Hospital
- Children's Hospital of Southwest Florida
- Joe Dimaggio Children's Hospital
- Ann and Robert H. Lurie Children's Hospital of Chicago
- University of Iowa Children's Hospital
- Our Lady of the Lake Children's Hospital
- Rutgers University
- Medical University of South Carolina
- T. C. Thompson Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Drug
Arm Description
MST-188
Outcomes
Primary Outcome Measures
Safety as measured as the incidence of adverse events
Secondary Outcome Measures
Rate of re-hospitalization for recurrence of VOC
Occurrence of acute chest syndrome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02449616
Brief Title
Evaluation of Repeat Administration of Purified Poloxamer 188
Acronym
EPIC-E
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mast Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle cell, vaso-occlusive crisis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Drug
Arm Type
Experimental
Arm Description
MST-188
Intervention Type
Drug
Intervention Name(s)
MST-188
Other Intervention Name(s)
vepoloxamer
Intervention Description
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Primary Outcome Measure Information:
Title
Safety as measured as the incidence of adverse events
Time Frame
30 days after administration of study drug
Secondary Outcome Measure Information:
Title
Rate of re-hospitalization for recurrence of VOC
Time Frame
Within 14 days of the date of discharge
Title
Occurrence of acute chest syndrome
Time Frame
Within 120 hours of registration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin L Parsley, D. O.
Organizational Affiliation
Mast Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
Country
United States
Facility Name
Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Joe Dimaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ann and Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa Children's Hospital
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Our Lady of the Lake Children's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
T. C. Thompson Children's Hospital
City
Chattanooga
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
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Evaluation of Repeat Administration of Purified Poloxamer 188
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