Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT02433158 |
Recruitment Status :
Terminated
(The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.)
First Posted : May 4, 2015
Last Update Posted : February 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Pain Crisis Vaso-occlusive Crisis | Drug: Rivipansel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Extension Study to Evaluate the Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease |
Actual Study Start Date : | December 16, 2015 |
Actual Primary Completion Date : | November 15, 2019 |
Actual Study Completion Date : | November 15, 2019 |

Arm | Intervention/treatment |
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Experimental: Cohort 1
Includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.
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Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Other Name: GMI-1070 |
Experimental: Cohort 2
Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).
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Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Other Name: GMI-1070 |
- Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study. [ Time Frame: 18 months ]Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
- Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study. [ Time Frame: 18 months ]Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
- Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study [ Time Frame: 18 months ]Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
- Number (%) of subjects with serious adverse events (SAEs) over the study. [ Time Frame: 18 months ]Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.
- Subject re hospitalization [ Time Frame: 18 months ]Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.

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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:
- Completion of Study B5201002.
- Documented diagnosis of SCD.
- At least 6 years of age.
- Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
- Diagnosis of VOC necessitating IV opioids and admission to the hospital.
- Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.
Exclusion Criteria:
- Non-compliance with study procedures in the double blind study (B5201002).
- Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
- Clinically significant deterioration in renal function in Study B5201002.
- Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
- Active use of illicit drugs and/or alcohol dependence.

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): NCT02433158

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | GlycoMimetics Incorporated |
ClinicalTrials.gov Identifier: | NCT02433158 |
Other Study ID Numbers: |
B5201003 |
First Posted: | May 4, 2015 Key Record Dates |
Last Update Posted: | February 10, 2021 |
Last Verified: | February 2021 |
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 |
Rivipansel GMI-1070 Selectin Inhibitor SCD VOC |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |