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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 21, 2016

Primary Completion Date

May 7, 2018

Study Completion Date

May 7, 2018

Conditions

Hepatitis C, Chronic

Interventions

DRUG

AL-335

Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

DRUG

Odalasvir (ODV)

Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

DRUG

Simeprevir (SMV)

Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Trial Locations (14)

Amagasaki-shi

Bunkyō City

Hiroshima

Kagoshima

Kurume-shi

Musashino-shi

Nagoya

Omura-shi

Osaka

Saitama

Sakaishi

Sapporo

Suita-shi

Yokohama