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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449616
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Mast Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 20, 2015
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)		 Safety as measured as the incidence of adverse events [ Time Frame: 30 days after administration of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • Rate of re-hospitalization for recurrence of VOC [ Time Frame: Within 14 days of the date of discharge ]
  • Occurrence of acute chest syndrome [ Time Frame: Within 120 hours of registration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Repeat Administration of Purified Poloxamer 188
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: MST-188
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Other Name: vepoloxamer
Study Arms  ICMJE Experimental: Study Drug
MST-188
Intervention: Drug: MST-188
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2016)		 16
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2015)		 388
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02449616
Other Study ID Numbers  ICMJE MST-188-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mast Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mast Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edwin L Parsley, D. O. Mast Therapeutics, Inc.
PRS Account Mast Therapeutics, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP