A Study to Evaluate the Safety, Tolerability, and Efficacy of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK2336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype-1 Hepatitis C Infected Patients

• Conditions: Chronic hepatitis C-infected patients; MedDRA version: 16.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-002555-42-BE
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-29
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

- Treatment-naive, documented prior relapse or null responder 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 availabe 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 >50 kg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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 oesopaghal 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

- Has participated in another clinical trial with an investigational drug, vaccine or device within 90 days prior to screening

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

- Any cardiac disease at screening, or any active clinical significant disease, or medical history or physical examination findings during screening that, in the investigator’s opinion, could compromise the outcome of the trial

- History or evidence of current abuse of alcohol (5 glasses/day during 5 years), barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator’s opinion would compromise subject’s safety and/or compliance with the study procedures

- Positive urine drug (with exclusion of methadone or equivalent) test at study screening

- Protocol-specified laboratory values

- Liver transplant, or any organ/tissue transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified