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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01740791 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection | PHASE1 | COMPLETED | 103 | — | — | Nov 6, 2012 | Jan 24, 2014 | Dec 16, 2020 | 10 | United States, Puerto Rico |
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.
| Arm | Type | Description |
|---|---|---|
| Velpatasvir 5 mg (GT 1a) | EXPERIMENTAL | Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 25 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 50 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 100 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 1b) | EXPERIMENTAL | Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 2) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 25 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 50 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 4) | EXPERIMENTAL | Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir up to 400 mg (GT 2) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Velpatasvir | DRUG | Tablets administered orally |
| Placebo | DRUG | Tablets administered orally |
Key Inclusion Criteria: * HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening * Agree to use protocol defined precautions against pregnancy Key Exclusion Criteria: * Chronic liver disease of a non-HCV etiology (e.g...