Trials / Terminated
TerminatedNCT02433158
Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- GlycoMimetics Incorporated · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).
Detailed description
This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivipansel | Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses. |
Timeline
- Start date
- 2015-12-16
- Primary completion
- 2019-11-15
- Completion
- 2019-11-15
- First posted
- 2015-05-04
- Last updated
- 2021-02-10
Locations
97 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02433158. Inclusion in this directory is not an endorsement.