Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01119833 | Study of GMI-1070 for the Treatment of Sickle Cell Pain Crisis | PHASE2 | COMPLETED | 81 | — | — | May 1, 2010 | Dec 1, 2013 | May 13, 2020 | 22 | United States, Canada |
| NCT00911495 | Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease | PHASE1 | COMPLETED | 15 | — | — | May 1, 2009 | Sep 1, 2010 | May 11, 2020 | 3 | United States |
Including pain score, feeling ready to leave the hospital, and actual time of leaving the hospital
| Arm | Type | Description |
|---|---|---|
| GMI-1070 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GMI-1070 | DRUG | Intravenous GMI-1070 given twice a day during hospital stay for sickle cell pain crisis |
| Placebo | DRUG | Intravenous Placebo given twice a day during hospital stay for sickle cell pain crisis |
Inclusion Criteria: 1. 12 to 60 years of age 2. Confirmed diagnosis of sickle cell disease (HbSS or HbS-β0thalassemia) 3. Diagnosis of VOC at the time of enrollment 4. Hospitalized or in process of admission at the time of enrollment 5. Able to receive the first dose of study drug within 24 hours o...