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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01852604 | Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005) | PHASE2 | COMPLETED | 143 | — | — | Mar 1, 2013 | Apr 1, 2015 | Apr 23, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 6 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV | EXPERIMENTAL | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks |
| Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV | EXPERIMENTAL | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Samatasvir | DRUG | Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets. |
| Simeprevir | DRUG | Simeprevir will be supplied as 75 and 150 mg oral capsules. |
| Ribavirin (RBV) | DRUG | Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
| TMC647055 | DRUG | TMC647055 will be supplied as 150 mg oral capsules. |
| Ritonavir (RTV) | DRUG | Ritonavir will be supplied as 80 mg/mL oral solution. |
| Pegylated interferon (Peg-IFN) | BIOLOGICAL | Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
| Samatasvir matching placebo | OTHER | Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A. |
Inclusion Criteria: * Must have Genotype 1a, 1b, 4 or 6 HCV infection. * Documented clinical history compatible with chronic hepatitis C * HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C) * Must agree to use an acceptable double method of birth control (one of which must be a barri...