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

COMPLETEDPHASE3

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

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

NCT02187003•Biossil Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (142)

University of South Alabama Children's and Women's Hospital

Mobile, Alabama, United States

Arkansas Children's Hospital Research Pharmacy

Little Rock, Arkansas, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

UC Davis Medical Center Main Hospital

Sacramento, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of Colorado CTRC

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

Howard University Center for Sickle Cell Disease

Washington D.C., District of Columbia, United States

Key Dates

Start Date

June 17, 2015

Primary Completion Date

May 3, 2019

Completion Date

June 27, 2019

Last Updated

March 11, 2025

Enrollment

345

ACTUAL participants

Conditions

Anemia, Sickle Cell

Interventions

Rivipansel

DRUG

Placebo

OTHER

European Rare Blood Disorders Platform (ENROL)

NCT06250595

AnemiaBone Marrow Failure+10 more

View study

ACTIVE_NOT_RECRUITINGNA

Therapeutic Response Evaluation and Adherence Trial (TREAT)

NCT02286154

Anemia, Sickle Cell

View study

TERMINATEDPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

European Rare Blood Disorders Platform (ENROL)

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