Evaluation of Repeat Administration of Purified Poloxamer 188
- Registration Number
- NCT02449616
- Lead Sponsor
- Mast Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Drug MST-188 MST-188
- Primary Outcome Measures
Name Time Method Safety as measured as the incidence of adverse events 30 days after administration of study drug
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
T. C. Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Joe Dimaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, 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
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Our Lady of the Lake Children's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States