Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

• Status: Completed
• Trial end date: 2017-11-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Odalasvir; Simeprevir

Criteria

Inclusion Criteria:

• Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection

• Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response

• Absence of cirrhosis

• Screening laboratory values within defined thresholds

• Must use specific contraceptive methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

• Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free

• Current or prior history of clinical hepatic decompensation

• History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol

• Pregnant or a nursing female