TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of TMC435 in combination with
      peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority
      compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously
      failed PegIFN.
    

Detailed description: 
      This study is a randomized (study drug assigned by chance like flipping a coin), double-blind
      (neither physician nor patient knows the name of the assigned drug), double-dummy (patients
      receive both active and inactive pills also called placebo), 2-arm, multicenter Phase III
      clinical study in adult treatment experienced Chronic Hepatitis C (CHC) genotype-1 infected
      patients who failed to respond during at least 1 previous course of PegINFα-2a/ RBV therapy.
      The purpose of the trial is to study the efficacy of TMC435 in combination with PegINFα-2a
      and RBV for 48 weeks of treatment compared to the approved regimen of telaprevir in
      combination with PegINFα-2a and RBV for 48 weeks of treatment. The study will consist of a
      screening period (maximum 6 weeks), treatment period (48 weeks) and post-treatment period
      (until 72 weeks after the start of treatment). For the first 12 weeks one group of patients
      will take TMC435 and TVR placebo, plus PegINFα-2a and RBV. The other group will take TMC435
      placebo and TVR, plus PegINFα-2a and RBV. After 12 weeks, patients in both arms will only
      take PegINFα-2a and RBV up to week 48. After patients stop taking study medication, they will
      continue to go to the doctor's office for study visits until a total of 72 weeks after they
      start study treatment. Patients will be monitored for safety throughout the study. Study
      assessments at each study visit may include, but are not limited to: blood and urine
      collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical
      activity of your heart), patient questionnaires, and physical examinations.
    

Intervention name(s): TMC435; TVR
Intervention type(s): Drug; Drug
Intervention description(s): TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.; TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435HPC3001; TMC435; Hepatitis C Virus (HCV); HEP C; Genotype 1; Treatment experienced; Null responders; Partial responders