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 August 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: August 2, 2014
Last verified: August 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
University of South Alabama Recruiting
Mobile, Alabama, United States, 36688
Contact: A Siddiqui    251-405-5172      
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Erica Olson       eolson1@phoenixchildrens.com   
United States, California
Harbor-UCLA Medical Center Recruiting
Torrence, California, United States, 90502
Contact: Helen Todoroki    310-222-4156    htodoroki@labiomed.org   
United States, Delaware
Al DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Lynn Marrs       lynn.marrs@nemours.org   
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20060
United States, Florida
Children's Hospital of SouthWest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Molly Arnstrom       Molly.arnstrom@leememorial.org   
Joe Dimaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Paulette Smith       PSmith@mhs.net   
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Vanessa Cumming    305-243-9431    v.cumming@med.miami.edu   
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Fabian Castillo    786-662-4146    Fabian.Castillo@mch.com   
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Laurie Barrett       Laurie.Barrett@jhmi.edu   
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Fife    813-844-7829    dafife@tgh.org   
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Betty Pace, MD    706-721-0174    bpace@gru.edu   
United States, Illinois
Children's Hospital at the University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Lani Krauz       lignacio@uic.edu   
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Jaclyn Janoski    312-227-4825    JJanoski@luriechildrens.org   
United States, Indiana
Fort Wayne Lutheran Hospital Recruiting
Ft. Wayne, Indiana, United States, 46804
Contact: Shelley Ramsey    260-435-2501    sramsey@lutheran-hosp.com   
United States, Iowa
University of Iowa-Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Natalie Kamberos, MD    319-384-5280      
United States, Kansas
Stormont-Vail Healthcare Recruiting
Topeka, Kansas, United States, 66606
Contact: Kayla Carpenter       kacarpen@stormontvail.org   
United States, Kentucky
University of Louisville/Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jennifer Comings       Jdcomi01@louisville.edu   
United States, Louisiana
Our Lady of the Lake Children's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Ryan M. Landry       ryan.landry@fmolhs.org   
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Angela Lala       alala@clinicaltrialscenter.org   
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Melody Benton       mbenton@tulane.edu   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Paul Kamate       pkamate1@jhmi.edu   
The Herman and Walter Samuelson Children's Hospital at Sinai Recruiting
Baltimore, Maryland, United States, 21215
Contact: Stephanie Entrup       Sentrup@lifebridgehealth.org   
United States, Michigan
Children's Hospital of Michigan-Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Theresa Spranger       tsprange@med.wayne.edu   
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Stefanie Pepper    601-815-9185    sellison@umc.edu   
United States, New Jersey
Rutger's University Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Julianne Wilson       wilsonj6@sn.rutgers.edu   
United States, New York
Bronx Lebanon Hospital Recruiting
Bronx, New York, United States, 10457
Contact: Grace Malonga       gmalonga@bronxleb.org   
NY Methodist Recruiting
Brooklyn, New York, United States, 11215
Contact: Carolyn Payne    718-780-5282    cap9020@nyp.org   
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Antonella Farrell       afarrell@nshs.edu   
Golisano Children's Hospital at URMC Recruiting
Rochester, New York, United States, 14642
Contact: S Noronha, MD    585-273-3159      
Contact: Cate Olin    585-273-3159    cate.olin@urmc.rochester.edu   
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David Gerard Wichlan       david_wichlan@med.unc.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kelly Thueneman       kelly.thueneman@cchmc.org   
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Catherine Tasi       catherine.tasi@uhhospitals.org   
United States, Oklahoma
Research Site Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Randall Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Martha Raschko    503-276-9376    MRaschko@lhs.org   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ashley Woodford       woodforda1@email.chop.edu   
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Angela Martino    412-692-6467    angela.martino2@chp.edu   
United States, South Carolina
The Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lisa Kuisel       kuisel@musc.edu   
East Carolina University Recruiting
Greenville, South Carolina, United States, 27834
Contact: Cynthia Brown       browncy@ecu.edu   
United States, Tennessee
T.C. Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 46236
Contact: Peggy Green    423-778-7024    Peggy.Green@erlanger.org   
United States, Texas
Cook's Children Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: Melinda Meacham       Melinda.Meacham@cookchildrens.org   
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Bogdan Dinu       brdinu@txch.org   
United States, Virginia
Children's Hospital of Richmond Recruiting
Richmond, Virginia, United States, 23298
Contact: India Sisler    804-628-0212      
Belgium
Reearch Center Recruiting
Antwerp, Belgium
Research Center Recruiting
Edgem, Belgium
Lebanon
Research Center Recruiting
Beirut, Lebanon
Research Center Recruiting
Tripoli, Lebanon
Oman
Research Center Recruiting
Muscat, Oman
Panama
Research Center Recruiting
Panama, Panama
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: August 2, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Lebanon: Ministry of Public Health
Oman: Ministry of Health, Sultanate of Oman
Panama: Ministry of Health, Panama

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 August 28, 2014