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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00623649 | Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection | PHASE1 | COMPLETED | 42 | — | — | Nov 1, 2007 | Oct 1, 2008 | Apr 4, 2014 | 5 | United States, Canada +1 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | VCH-916 100 mg three times a day (t.i.d.) |
| Cohort 2 | EXPERIMENTAL | VCH-916 200 mg (t.i.d.) |
| Cohort 3 | EXPERIMENTAL | VCH-916 300 mg twice daily for three days |
| cohort 4 | EXPERIMENTAL | VCH-916 400 mg twice daily for three days |
| Name | Type | Description |
|---|---|---|
| VCH 916 | DRUG | Dose escalation study with a full review of all safety data following each cohort. |
| Placebo | DRUG | Dose escalation study with a full review of all safety data following each cohort. |
Inclusion Criteria: * Males and females 18 to 60 years of age * No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3 * Subject's liver disease is stable with ALT values \< 5 X ULN * Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening * D...