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
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Cook Children's Hematology/Oncology Center
Fort Worth, Texas 76104
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Brigham and Women's Hosp
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University of Chicago Comer Children's Hospital
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University of Cincinnati Medical Center
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Cincinnati, Ohio 45229
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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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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
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Children's Hospital of Philadelphia
South 34th Street
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Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
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Rhode Island Hospital
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UC Davis Medical Center
Sacramento, California 95814
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University of South Florida
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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
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Atlanta, Georgia 30322
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Atlanta, Georgia 30303
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Atlanta, Georgia 30322
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Augusta, Georgia 30912
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Augusta, Georgia 30912
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Augusta, Georgia 30912
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Aurora, Colorado 80045
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St. Jude Affiliate Clinic
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Baton Rouge, Louisiana 70809
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Boston Children's Hospital
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Boston, Massachusetts 02118
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Medical University of South Carolina Hospital
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Medical University of South Carolina
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Charleston, South Carolina 29425
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Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
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University of Chicago, Investigational Drug Service Pharmacy
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Cincinnati, Ohio 45219
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Children's Medical Center
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3901 Beaubien St
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Duke Univ Med Ctr
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Cook Children's Medical Center
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Cook Children's Hematology/Oncology Center-Grapevine
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East Carolina University Brody School of Medicine
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Leo W. Jenkins Cancer Center
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UT Physicians Comprehensive Sickle Cell Center Houston
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