Phase 3
N=345
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Anemia, Sickle Cell
Bottom Line
View on ClinicalTrials.gov: NCT02187003 ↗Enrolled (actual)
345
Serious AEs
31.6%
Results posted
Mar 2025
Primary outcome: Primary: Time to Readiness for Discharge From Hospital — 87.78; 93.47 Hours — p=0.7944
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivipansel (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Biossil Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Readiness for Discharge From Hospital |
87.78; 93.47 | 0.7944 |
| SECONDARY Time to Discharge From Hospital |
86.75; 90.67 | 0.7156 |
| SECONDARY Cumulative Intravenous (IV) Opioids Consumption From Time of Loading Dose of Study Drug to Discharge From Hospital |
2.30; 2.36 | 0.8520 |
| SECONDARY Time to Discontinuation of Intravenous (IV) Opioids |
67.20; 68.45 | 0.8593 |
| SECONDARY Cumulative Intravenous (IV) Opioids Consumption Within First 24 Hours Post-Loading Dose of Study Drug |
0.80; 0.82 | 0.9332 |
| SECONDARY Percentage of Participants Re-hospitalized for Vaso-Occlusive Crisis (VOC) Within 3 Days of Discharge From Hospital |
3; 5 | 0.5349 |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT02187003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.