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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01126086 | Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment | PHASE1 | COMPLETED | 25 | — | — | May 1, 2010 | Apr 1, 2011 | May 8, 2014 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Mild impairment | EXPERIMENTAL | Patients with mild hepatic impairment |
| Moderate impairment | EXPERIMENTAL | Patients with moderate impairment |
| Healthy subjects | EXPERIMENTAL | Matched healthy subjects |
| Name | Type | Description |
|---|---|---|
| otamixaban XRP0673 | DRUG | Pharmaceutical form: solution for injection Route of administration: intravenous |
Inclusion criteria: \- Subjects with hepatic impairment: * Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive * Stable chronic liver disease assessed by medical history, physical examin...