A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genoty

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and low-dose ritonavir, administered together with and without ribavirin and of TMC647055, TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a limited number of patients with chronic hepatitis C virus (HCV) infection.

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

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Cytochrome P-450 CYP3A Inhibitors; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin; Ritonavir; Simeprevir

Criteria

Inclusion Criteria:

• Documented chronic genotype 1a or genotype 1b hepatitis C virus (HCV) infection with HCV ribonucleic acid (RNA) level >100,000 IU/mL at screening

• Treatment-naive or documented prior relapser to previous treatment regimens and has stopped treatment at least 3 months before screening

• Liver biopsy within 3 years before the screening visit or elastography results available prior to first study drug dosing

• Medically stable based on physical examination, medical history, vital signs, and electrocardiogram performed at screening

• Body mass index of 18.0 to 32.0 kg/m2 and body weight more than 50 kg

Exclusion Criteria:

• Evidence of liver cirrhosis by liver biopsy or the presence of esophageal varices or a transient elastography result of >14.6 kPa within 2 years prior to first dosing

• Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices

• Evidence of any significant liver disease in addition to hepatitis C (including but not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis)

• Receiving or has received any HCV-specific direct antiviral agent (HCV protease inhibitors, HCV nucleoside polymerase inhibitors, HCV non-nucleoside polymerase inhibitors, HCV NS5a inhibitors or any other HCV inhibitor targeting an HCV protein or a target involved in the HCV replication cycle

• Co-infected with human immunovirus (HIV)-1 or HIV-2, with non-genotype 1a/1b HCV, or hepatitis A or B virus infection