Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT02187003 |
Recruitment Status :
Completed
First Posted : July 10, 2014
Last Update Posted : June 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia, Sickle Cell | Drug: Rivipansel Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 345 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | June 17, 2015 |
Actual Primary Completion Date : | May 3, 2019 |
Actual Study Completion Date : | June 25, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Rivipansel Treatment Arm |
Drug: Rivipansel
Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.
Other Name: GMI-1070 |
Placebo Comparator: Placebo Treatment Arm |
Other: Placebo
Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
Other Name: phosphate buffered saline |
- Time to readiness-for-discharge. [ Time Frame: Assessments will be every 4 hours (from 6am to 10pm, daily) for the duration of hospitalization, an expected average of 5 days ]Time to readiness-for-discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.
- Time to discharge. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]Time to discharge, is the difference between the time and date of hospital discharge order and the time and date of start of the first infusion of study drug.
- Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
- Time to discontinuation of IV opioids. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]Time to discontinuation of IV opioids.
- Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug. [ Time Frame: Day 1 ]Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
- Percent of subjects re-hospitalized for VOC within 3 days of discharge. [ Time Frame: Within 3 days of discharge ]Percent of subjects re-hospitalized for VOC within 3 days of discharge.

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187003

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | GlycoMimetics Incorporated |
ClinicalTrials.gov Identifier: | NCT02187003 |
Other Study ID Numbers: |
B5201002 RESET ( Other Identifier: Alias Study Number ) |
First Posted: | July 10, 2014 Key Record Dates |
Last Update Posted: | June 22, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders pain crisis vaso-occlusive crisis |
rivipansel GMI-1070 selectin inhibitor SCD VOC |
Anemia, Sickle Cell Anemia Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |