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Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC)

This study is currently recruiting participants.
Verified April 2013 by Mast Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01737814
First received: November 27, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate whether ANX-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether ANX-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 ANX-188 to those who do not receive ANX-188.


Condition Intervention Phase
Vaso-occlusive Crisis
Sickle Cell Disease
 Drug: ANX-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 Children in Crisis (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of ANX-188 (Purified Poloxamer 188) Injection in Children With Sickle Cell Disease Experiencing Vaso Occlusive Crisis

Resource links provided by NLM:

U.S. FDA Resources

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: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANX-188
ANX-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: ANX-188
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
 Drug: Saline

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 8 through 17 years
  • Subject has a confirmed diagnosis of HbSS 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 prior 14 days or has experienced > 6 hospitalizations for VOC in the prior 12 months
  • Subject has chronic, recent, or anticipated blood transfusions
  • Subject is hospitalized for a condition other than VOC
  • Subject has complications related to SCD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737814

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

Locations
United States, Louisiana
Research Site Recruiting
New Orleans, Louisiana, United States, 70118
United States, North Carolina
Research Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Research Center Recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Site Recruiting
Fort Worth, Texas, United States, 76104
Research Site Recruiting
Houston, Texas, United States, 77030
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: ANX-188-01
Study First Received: November 27, 2012
Last Updated: April 2, 2013
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 May 22, 2013