Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 3/16/2019 |
| Start Date: | June 17, 2015 |
| End Date: | June 22, 2019 |
| Contact: | Pfizer CT.gov Call Center |
| Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
| Phone: | 1-800-718-1021 |
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
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.
treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing
a pain crisis necessitating hospitalization.
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
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