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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00983060 | Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients | PHASE2 | COMPLETED | 59 | — | — | Sep 1, 2009 | - | Dec 19, 2020 | 16 | United States, Australia +5 |
| Arm | Type | Description |
|---|---|---|
| NIM811 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NIM811 | DRUG | BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV) |
| Placebo BID + SOC | DRUG | Placebo BID + SOC (PEG IFN and RBV) |
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: * chronic hepatitis C genotype-1 * HCV-RNA should be ≥ 4 x 105 IU/mL at screening * Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documen...