Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter J. Ruane, M.D.
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Simeprevir; Sofosbuvir

Criteria

Inclusion Criteria:

• HCV genotype 4 infection

• HCV RNA >10,000 IU/mL at screening.

Exclusion Criteria:

• Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).

• Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.

• Infection/co-infection with HCV non-genotype 4.

• Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).

• Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).

• Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator

• Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.