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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: MST-188 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Drug
MST-188
 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured as the incidence of adverse events [ Time Frame: 30 days after administration of study drug ]

Secondary Outcome Measures :
  1. Rate of re-hospitalization for recurrence of VOC [ Time Frame: Within 14 days of the date of discharge ]
  2. Occurrence of acute chest syndrome [ Time Frame: Within 120 hours of registration ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449616


Locations
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United States, California
Rady Children's Hospital
San Diego, California, United States
United States, Florida
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Joe Dimaggio Children's Hospital
Hollywood, Florida, United States, 33021
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States
United States, Louisiana
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, United States, 70808
United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Tennessee
T. C. Thompson Children's Hospital
Chattanooga, Tennessee, United States
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
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Study Director: Edwin L Parsley, D. O. Mast Therapeutics, Inc.
More Information
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Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02449616    
Other Study ID Numbers: MST-188-04
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Mast Therapeutics, Inc.:
Sickle cell
vaso-occlusive crisis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn