Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus Infection Simeprevir Sofosbuvir HCV Cirrhosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 103
Healthy volunteers: no

Brief summary:
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

Detailed description:
This is a open-label (all people know the identity of the intervention), single arm, multicenter study. The study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 40 weeks.

Arms:
arm 1: 100 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.

Interventions: intervention 1: Simeprevir intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: 100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks. intervention 2: 100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.

Protocol document: