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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02993250 | A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive | PHASE2 | COMPLETED | 33 | — | — | Dec 21, 2016 | May 7, 2018 | Sep 11, 2019 | 14 | Japan |
| NCT02765490 | Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection | PHASE2 | COMPLETED | 365 | — | — | Nov 9, 2016 | Nov 16, 2017 | Nov 20, 2019 | 28 | Belgium, Canada +4 |
An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Chronic Hepatitis C Without Cirrhosis) | EXPERIMENTAL | Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. |
| Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) | EXPERIMENTAL | Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC). |
| Group A | EXPERIMENTAL | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks. |
| Group B | EXPERIMENTAL | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks. |
| Name | Type | Description |
|---|---|---|
| AL-335 | DRUG | Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Odalasvir (ODV) | DRUG | Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Simeprevir (SMV) | DRUG | Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Odalasvir | DRUG | Odalasvir 25 mg tablet will be administered once daily. |
| Simeprevir | DRUG | Simeprevir 75 mg capsule will be administered once daily. |
Inclusion Criteria: * Chronic hepatitis C virus (HCV) infection * All participants must have HCV genotype 1 or 2 infection, determined at screening * HCV ribonucleic acid (RNA) plasma levels greater than or equal to (\>=)10,000 international units per Milliliter (IU/mL), determined at screening * D...