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
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University of Maryland Medical System
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Jackson Memorial Hospital
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