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Trial record 1 of 1 for:    NCT01737814
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Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC) (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737814
First Posted: November 30, 2012
Last Update Posted: October 28, 2016
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.
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
November 27, 2012
November 30, 2012
October 28, 2016
May 2013
February 2016   (Final data collection date for primary outcome measure)
Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease. [ Time Frame: Study participants will be followed for the duration of hospital stay, an expected average of 4 days ]
Same as current
Complete list of historical versions of study NCT01737814 on ClinicalTrials.gov Archive Site
  • Re-hospitalization rate for VOC [ Time Frame: Hospital discharge to 14 days post-discharge ]
  • Occurence of acute chest syndrome [ Time Frame: Randomization to 120 hours after randomization ]
Same as current
Not Provided
Not Provided
 
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial 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 whether MST-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Vaso-occlusive Crisis
  • Sickle Cell Disease
  • Drug: Saline
  • Drug: MST-188
    Other Name: vepoloxamer
  • Experimental: MST-188
    MST-188 injection administered as a continuous infusion 100 mg/kg for 1 hour followed by 30 mg/kg/hr for up to 48 hours.
    Intervention: Drug: MST-188
  • Placebo Comparator: Saline
    Saline administered as a continuous infusion for up to 49 hours
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
Not Provided
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 4 through 65 years
  • Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal
  • Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral 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 or has experienced > 5 hospitalizations for VOC in the prior 6 months
  • Subject has been transfused within the past 14 days
  • Subject is hospitalized for a condition other than VOC
  • Subject has complications related to SCD
Sexes Eligible for Study: All
4 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Dominican Republic,   Jamaica,   Jordan,   Lebanon,   Oman,   Panama,   Spain,   Turkey,   United States
 
 
NCT01737814
MST-188-01
Yes
Not Provided
Not Provided
Mast Therapeutics, Inc.
Mast Therapeutics, Inc.
Not Provided
Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.
Mast Therapeutics, Inc.
October 2016

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