Chronic hepatitis C-infected patients MedDRA version: 16.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: JNJ-42039556-AMR-G-001, 150 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: JNJ-42039556-AMR
Other descriptive name: TMC647055, R601380
Conce
Sponsors
Janssen R&D Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate safety and tolerability of 12 weeks dosing regimen containing TMC647055 once daily (q.d.), TMC435 q.d., and RTV q.d., at selected doses with and without RBV (2 daily doses) in chronic HCV genotype 1 infected (cHCV GT1) patients - Evaluate efficacy of 12 weeks combination therapy of TMC647055 q.d., TMC435 q.d. and RTV q.d., at selected doses with RBV (2 daily doses) in treatment-naïve/prior relapser (TN/PR) cHCV GT1 patients - Evaluate efficacy of 12 weeks combination therapy of TMC647055 q.d., TMC435 q.d. and RTV q.d., at selected doses in TN/PR cHCV genotype-1b infected patients - Evaluate plasma PK of TMC647055, TMC435 and RTV of 12 weeks dosing regimen containing TMC647055 q.d., TMC435 q.d., RTV q.d., at selected doses with and without RBV (2 daily doses) - Evaluate safety, tolerability, PK and efficacy of 12 weeks combination therapy of TMC435 q.d., TMC647055 q.d., RTV q.d. and GSK2336805 q.d. without RBV, in a population of TN/PR cHCV GT1 patients;Secondary Objective: Not Applicable;Primary end point(s): - Proportion of subjects with a sustained virologic response (SVR) 12 weeks after the actual end of treatment. SVR12 is defined as undetectable HCV RNA at the actual end of treatment and HCV RNA < 25 IU/mL at 12 weeks after the actual end of treatment - Proportion of subjects with adverse events and SAEs - abnormal changes in safety related laboratory values - abnormal changes in vital signs and physical examination - abnormal electrocardiogram (ECG) [Timeframe = up to 24 weeks after actual end of treatment] ;Timepoint(s) of evaluation of this end point: week 24 for the 12 week direct antiviral treatment duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects with a sustained virologic response (SVR) 12 weeks after the actual end of treatment. [Timeframe: 12 weeks after actual end of treatment] - Proportion of subjects with a sustained virologic response (SVR) 4 weeks after the actual end of treatment. [Timeframe: 4 weeks after actual end of treatment] - Proportion of subjects with a sustained virologic response (SVR) 24 weeks after the actual end of treatment. [Timeframe: 24 weeks after actual end of treatment] - HCV RNA levels over time [Time frame = up to 24 weeks after actual end of treatment] - Proportion of subjects with undetectable hepatitis C virus (HCV) RNA (<25 IU/mL undetectable) and/or HCV RNA levels <25 IU/mL at all time points [Time frame = up to 24 weeks after actual end of treatment] - Proportion of subjects with on-treatment virologic failure [Time frame = up to actual end of treatment] - Proportion of subjects with viral relapse [Time frame = up to 24 weeks after actual end of treatment] - Proportion of subjects with presence of HCV variants associated with reduced susceptibility to investigational treatment [Time frame = up to 24 weeks after actual end of treatment] - PK parameters of TMC435, TMC647055 and RTV and GSK2336805 at Week 4;Timepoint(s) of evaluation of this end point: see section E.5.2 | — |
Countries
Belgium
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed