Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:4 - 65
Updated:4/21/2016
Start Date:May 2013
Contact:Mast Therapeutics CT.gov Call Center
Phone:1-888-965-1238

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
51
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
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T.C. Thompson Children's Hospital
910 Blackford street
Chattanooga, Tennessee 37403
Phone: 423-778-7024
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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Rainbow Babies and Children's Hospital
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
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Children's Hospital of Southwest Florida
9981 South Healthpark Drive
Fort Myers, Florida 33908
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Joe DiMaggio Children's Hospital
1000 Joe DiMaggio Drive
Hollywood, Florida 33021
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Phone: 601-815-9185
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University of Miami
Miami, Florida 33124
(305) 284-2211
Phone: 305-243-9431
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Miami Children's Hospital
3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Phone: 786-662-4146
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Children's Hospital of The King's Daughters
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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Tampa General Hospital
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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Reearch Center
Antwerp,
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Grady Memorial Hospital
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
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Augusta University
1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
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Johns Hopkins
Baltimore, Maryland 21218
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The Herman and Walter Samuelson Children's Hospital at Sinai
Baltimore, Maryland 21215
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Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana 70808
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Bronx/Lebanon Hospital
Bronx, New York 10457
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NY Methodist
Brooklyn, New York 11215
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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University of Virginia Medical Center
Charlottsville, Virginia 22908
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Ann & Robert H. Lurie Children's Hospital of Chicago
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-4825
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Children's Hospital of the University of Illinois
Chicago, Illinois 60612
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Children's Hospital of Michigan, Wayne State University
Detroit, Michigan 48201
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Hurley Research Center
Flint, Michigan 48503
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Cook's Children Hospital
Fort Worth, Texas 76104
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Fort Wayne Lutheran Hospital
7950 West Jefferson Boulevard
Ft. Wayne, Indiana 46804
Phone: 260-435-2501
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East Carolina University
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
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Texas Children's Hospital
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
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Riley Hospital for Children
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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University of Iowa Children's Hospital
Iowa City, Iowa 52242
Phone: 319-384-5280
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University of Louisville/Kosair Children's Hospital
Louisville, Kentucky 40202
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University of South Alabama
307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
Phone: 251-405-5172
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Rutgers University
New Brunswick, New Jersey 08901
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Cohen Children's Medical Center
New Hyde Park, New York 11040
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Children's Hospital of New Orleans
New Orleans, Louisiana 70118
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UCSF Benioff Children's Hospital
Oakland, California 94609
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Phoenix Children's Hospital
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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Children's Hospital of Pittsburgh
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Phone: 412-692-6467
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University of Pittsburgh Medical Center
200 Lothrop St
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Randall Children's Hospital
Portland, Oregon 97227
Phone: 503-276-9376
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Children's Hospital of Richmond
Richmond, Virginia 23298
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Golisano Children's Hospital at URMC
Rochester, New York 14642
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University of California at Davis Health System
Sacramento, California 95817
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Rady Children's Hosptial
San Diego, California 92123
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All Children's Hospital
501 6th Avenue South
St. Petersburg, Florida 33701
(727) 898-7451
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Harbor-UCLA Medical Center
Torrence, California 90502
Phone: 310-222-4156
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Howard University
Washington, District of Columbia 20060
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Al DuPont Hospital for Children
Wilmington, Delaware 19803
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