A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus
      (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser
      or non-responder to Interferon-based therapy) in Japan.
    

Detailed description: 
      This is an open-label study (all people involved know the identity of the intervention) to
      evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in
      combination with the standard of care therapy (SoC: peginterferon [pegIFN] alfa-2b and
      ribavirin) in adult, genotype 1 hepatitis C virus (HCV)-infected participants who are
      treatment-naive (never received treatment for HCV), prior relapsers (relapsed after previous
      interferon [IFN]-based therapy), or non-responders (failed to respond to previous IFN-based
      therapy) in Japan. The study objective is to evaluate the efficacy, safety, and
      pharmacokinetics of TMC435. A sufficient number of participants who are treatment-naive,
      prior relapsers to treatment with IFN-based therapy, and prior non-responders to treatment
      with IFN-based therapy will be enrolled and assigned to 1 of 3 panels (referred to as
      treatment groups). Participants who are treatment-naive or prior relapsers to IFN-based
      therapy will receive 12 weeks of treatment with TMC435 (100 mg) once daily with pegIFN
      alfa-2b and ribavirin (PR) followed by an additional 12 or 24 weeks of treatment with PR.
      Participants who are non-responders to IFN-based therapy will receive 12 weeks of treatment
      with TMC435 (100 mg) once daily with PR followed by an additional 36 weeks of treatment with
      PR. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment will
      consist of Pegylated interferon (PegIFN alpha-2b) (1.5 mcg/kg) injected with a syringe
      subcutaneously (under the skin) once weekly and ribavirin 200-mg capsules (daily dose:
      600-1000 mg based on body weight) taken orally by mouth 2 times a day after meals for 24 or
      48 weeks.
    

Intervention name(s): TMC435; Peginterferon alfa-2b (pegIFN alfa-2b); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg capsule taken by mouth once daily for 12 weeks; PegIFN alfa-2b will be supplied as a vial containing dried and frozen powder with 74,148 or 222 mcg pegIFN alpha-2b attached to 0.7 ml injection water (50, 100 or 150 mcg/0.5mL pegIFN alpha-2b) and will be administered according to the manufacturer's prescribing information as 1.5 mcg/kg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.; The dose of RBV given will be based on body weight. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 capsules of 200 mg) after breakfast and 600 mg (3 capsules of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 capsules of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 capsule of 200 mg) after breakfast and 400 mg (2 capsules of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Other intervention name(s): PEGINTRON; REBETOL
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Simeprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; TMC435; Hepatitis C; Hepatitis C virus; Interferon Alfa-2b; Ribavirin; Viral ribonucleic acid