Evaluation of Repeat Administration of Purified Poloxamer 188
EPIC-E
1 other identifier
interventional
16
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedOctober 28, 2016
October 1, 2016
1.3 years
May 18, 2015
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as measured as the incidence of adverse events
30 days after administration of study drug
Secondary Outcomes (2)
Rate of re-hospitalization for recurrence of VOC
Within 14 days of the date of discharge
Occurrence of acute chest syndrome
Within 120 hours of registration
Study Arms (1)
Study Drug
EXPERIMENTALMST-188
Interventions
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Rady Children's Hospital
San Diego, California, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Joe Dimaggio Children's Hospital
Hollywood, Florida, 33021, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, 70808, United States
Rutgers University
New Brunswick, New Jersey, United States
Medical University of South Carolina
Charleston, South Carolina, United States
T. C. Thompson Children's Hospital
Chattanooga, Tennessee, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Edwin L Parsley, D. O.
Mast Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 20, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10