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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mast Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01737814
First received: November 27, 2012
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Vaso-occlusive Crisis
Sickle Cell Disease
Drug: MST-188
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-hospitalization rate for VOC [ Time Frame: Hospital discharge to 14 days post-discharge ] [ Designated as safety issue: No ]
  • Occurence of acute chest syndrome [ Time Frame: Randomization to 120 hours after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 388
Study Start Date: May 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: MST-188
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
Drug: Saline

  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737814

Contacts
Contact: Mast Therapeutics CT.gov Call Center 1-888-965-1238

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Mobile, Alabama, United States, 36688
United States, Arizona
Research Site Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Research Site Recruiting
Torrence, California, United States, 90502
United States, Delaware
Research Site Recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20060
United States, Florida
Research Site Recruiting
Fort Myers, Florida, United States, 33908
Research Site Recruiting
Hollywood, Florida, United States, 33021
Research Site Recruiting
Miami, Florida, United States, 33155
Research Site Recruiting
Miami, Florida, United States, 33136
Research Site Recruiting
St. Petersburg, Florida, United States, 33701
Research Site Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Research Site Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 61612
Research Site Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Research Site Recruiting
Ft. Wayne, Indiana, United States, 46804
United States, Iowa
Research Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Research Site Recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Research Site Recruiting
Baton Rouge, Louisiana, United States, 70808
Research Site Recruiting
New Orleans, Louisiana, United States, 70112
Research Site Recruiting
New Orleans, Louisiana, United States, 70118
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21205
Research Site Recruiting
Baltimore, Maryland, United States, 21215
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48201
United States, Mississippi
Research Site Recruiting
Jackson, Mississippi, United States, 39216
United States, New Jersey
Research Site Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
Research Site Recruiting
Bronx, New York, United States, 10457
Research Site Recruiting
Brooklyn, New York, United States, 11215
Research Site Recruiting
New Hyde Park, New York, United States, 11040
Research Site Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Research Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45229
Research Site Recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Research Site Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Research Site Recruiting
Charleston, South Carolina, United States, 29425
Research Site Recruiting
Greenville, South Carolina, United States, 27834
United States, Tennessee
Research Site Recruiting
Chattanooga, Tennessee, United States, 46236
United States, Texas
Research Site Recruiting
Fort Worth, Texas, United States, 76104
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Research Site Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
Study Director: Santosh Vetticaden, PhD, MD Mast Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01737814     History of Changes
Other Study ID Numbers: MST-188-01
Study First Received: November 27, 2012
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mast Therapeutics, Inc.:
sickle cell disease
vaso-occlusive crisis

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 29, 2014