Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:6 - Any
Updated:3/16/2019
Start Date:June 17, 2015
End Date:June 22, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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Trial Summary
Trial Overview
Inclusion Criteria

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RIVIPANSEL (GMI-1070) IN THE TREATMENT OF VASO-OCCLUSIVE CRISIS IN HOSPITALIZED SUBJECTS WITH SICKLE CELL DISEASE

This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in
treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing
a pain crisis necessitating hospitalization.


Inclusion Criteria:

- At least 6 years of age.

- Documented diagnosis of sickle cell disease.

- Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with
treatment including IV opioids.

- Able to receive the first dose of study drug within 24 hours from the administration
of IV opioids.

Exclusion Criteria:

- Serious systemic infection

- Acute Chest Syndrome

- Serious concomitant medical problems (for example, stroke)

- SCD pain atypical of VOC

- Severe renal or hepatic impairment

- Chronic pain rather than a presentation of acute VOC
We found this trial at
137
sites
Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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Brigham and Women's Hosp
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Chicago Comer Children's Hospital
5721 S. Maryland Avenue
Chicago, Illinois 60637
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University of Cincinnati Medical Center
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson Memorial Hospital
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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University of Miami
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Rhode Island Hospital
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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UC Davis Medical Center
Sacramento, California 95814
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Tampa General Hospital
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Children's Healthcare of Atlanta/Aflac Cancer and Blood Disorders Center
Atlanta, Georgia 30303
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Children's Healthcare of Atlanta/Aflac Cancer and Blood Disorders Center
Atlanta, Georgia 30303
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Emory Children's Center
Atlanta, Georgia 30322
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Children's Healthcare of Atlanta/Aflac Cancer and Blood Disorders Center
Atlanta, Georgia 30303
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Grady Health System
Atlanta, Georgia 30303
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Children's Healthcare of Atlanta
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
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Children's Healthcare of Atlant a Aflac Cancer and Blood Disorders Center / Scottish Rite Outpatient
Atlanta, Georgia 30342
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Augusta University Medical Center
Augusta, Georgia 30912
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Augusta University
Augusta, Georgia 30912
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Augusta University Clinical Research Pharmacy
1120 15th Street
Augusta, Georgia 30912
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University of Colorado CTRC
Aurora, Colorado 80045
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University of Colorado Hospital
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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Johns Hopkins Medicine
Baltimore, Maryland 21231
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Johns Hopkins University School of Medicine
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
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Johns Hopkins Medicine
Baltimore, Maryland 21231
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University of Maryland Medical System Investigational Pharmacy
22 S Greene St
Baltimore, Maryland 21201
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University of Maryland Medical System
Baltimore, Maryland 21201
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St. Jude Affiliate Clinic
Baton Rouge, Louisiana 70808
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Our Lady of the Lake Physician Group-Medical Oncology
Baton Rouge, Louisiana 70809
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Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston Medical Center E7E
Boston, Massachusetts 02118
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Boston Med Ctr
Boston, Massachusetts 02118
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Boston University Medical Center
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
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Center for Clinical Investigation, Brigham and Women's Hospital
75 Francis Street
Boston, Massachusetts 02115
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Investigational Drug Services
Boston, Massachusetts 02115
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Jacobi Medical Center
1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
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Kings County Hospital Center
Brooklyn, New York 11203
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Kings County Hospital Center - Pharmacy Department
Brooklyn, New York 11203
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State University of New York (SUNY)-Downstate Medical Center
Brooklyn, New York
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Downstate Medical Center State Univ of NY HLTH SCI CTR PHMCY
450 Clarkson Avenue
Brooklyn, New York 11203
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Medical University of South Carolina Hospital
Charleston, South Carolina 29403
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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MUSC, Investigational Drug Services
Charleston, South Carolina 29425
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Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
Charleston, South Carolina 29425
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University of Chicago, Investigational Drug Service Pharmacy
Chicago, Illinois 60637
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University of Illinois at Chicago Clinical Research Center
Chicago, Illinois 60612
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University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60612
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University of Cincinnati Medical Center/ Investigational Pharmacy
Cincinnati, Ohio 45219
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University of Cincinnati Medical Center/Research Office
Cincinnati, Ohio 45219
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University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio 45267
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University of Cincinnati- Hoxworth Building
Cincinnati, Ohio 45219
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UC Health Ridgeway Hospital
Cincinnati, Ohio 45229
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The Ohio State University Investigational Drug Services
Columbus, Ohio 43210
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The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
Columbus, Ohio 43210
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The Ohio State University Wexner Medical Center East
Columbus, Ohio 43210
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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Children's Medical Center
Dallas, Texas 75235
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Five Rivers Medical Surgical Health Center
Dayton, Ohio 45402
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Miami Valley Hospital
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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Children's Hospital of Michigan
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
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Detroit Medical Center Pharmacy
Detroit, Michigan 48201
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Wayne State University/Detroit Receiving Hospital
Detroit, Michigan 48201
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Duke University Hospital
Durham, North Carolina 27705
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Royal Alexandra Hospital
Edmonton, Alberta
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Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
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Cook Children's Hematology/Oncology Center
Fort Worth, Texas 76104
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Cook Children's Medical Center
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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UF Health Davis Cancer Pavillion and Shands Med Plaza
Gainesville, Florida 32608
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UF Health Shands Cancer Hospital
Gainesville, Florida 32608
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UF Health Shands Hospital
Gainesville, Florida 32610
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Cook Children's Hematology/Oncology Center-Grapevine
Grapevine, Texas
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East Carolina University Brody School of Medicine
Greenville, North Carolina
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Leo W. Jenkins Cancer Center
Greenville, North Carolina 27834
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Vidant Medical Center
Greenville, North Carolina 27834
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East Carolina University
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
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UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas 77004
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Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
Houston, Texas 77030
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Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas 77030
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Memorial Hermann/UT Cancer Center - Texas Medical Center
Houston, Texas 77030
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University of Texas Medical School
Houston, Texas 77030
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Texas Children´s Hospital - Investigational Pharmacy
Houston, Texas 77030
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Texas Children´s Hospital - Main Hospital
Houston, Texas 77030
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Texas Children's Hospital- Wallace Tower
Houston, Texas 77030
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University of Mississippi Medical Center-Outpatient Clinical Research Unit
2500 North State Street
Jackson, Mississippi 39216
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Children´s Mercy Hospital
2401 Gillham Road
Kansas city, Missouri 64108
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Arkansas Children's Hospital Research Pharmacy
1 Children's Way
Little Rock, Arkansas 72202
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Arkansas Children's Hospital
1 Children's Way
Little Rock, Arkansas 72202
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Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky 40202
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University of Louisville Health Sciences Center
Louisville, Kentucky 40205
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University of Louisville Physicians Pediatric Hematology Oncology
Louisville, Kentucky 40202
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Norton Children´s Hospital
Louisville, Kentucky 40202
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University of South Alabama, Children's and Women's Hospital
Mobile, Alabama 36604
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The Bristol-Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
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Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903
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New Brunswick, New Jersey 08903
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