A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in
      combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both
      treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4
      infected patients.
    

Detailed description: 
      This is an open-label (both participant and investigator know the name of the medication
      given at a certain moment), single arm Phase III study, with 3 subpopulations: treatment
      naive, previous HCV relapser and previous HCV non-responders. The study will consist of 3
      phases: a screening phase of maximum 6 Weeks, an open-label treatment phase of 24 to 48 Weeks
      for treatment naive patients and relapsers (response guided treatment) and 48 Weeks for
      non-responders, followed by a 24 Week follow-up period. The duration of participation in the
      study for an individual participant will be up to 54 to 78 (including screening).

      Part Ia: All participants will receive 12 Weeks of triple therapy with TMC435 (150mg once
      daily [q.d.]), PegINF-alfa-2a (180µg per Week) and RBV (1000 to 1200 mg per day, based on
      weight), followed by 12 Weeks of PegINF-alfa-2a (180µg per Week) and RBV (1000 to 1200 mg per
      day, based on weight).

      Part Ib: Participants who will need to continue treatment for another 24 Weeks
      (non-responders + treatment naive and relapser patients who need to continue treatment
      according to the response guided treatment criteria) will receive an additional 24 Weeks of
      PegINF-alfa 2a (180 mg per Week) and RBV (1000 to 1200 mg per day, based on weight).

      Part II: 24 Week follow-up period for all participants, starting after Week 24 or Week 48.

      In Part Ia, participants will have to come for 6 visits during the first month, followed by a
      visit once every month until Week 24 (in total 11 visits- Day1, day 3, Day 7, Day 14, day 28,
      Week 8, Week 12, Week 16, Week 20 and Week 24) at which safety, efficacy and tolerability
      will be checked.

      In Part Ib, participants will have to come for 4 additional visits (Week 28, Week 36, Week 42
      and Week 48) at which safety, tolerability and efficacy will be checked In the follow-up
      period, participants will have to come for an additional 3 visits (either Week 28, Week 36
      and Week 28 or Week 52, Week 60 and Week 72) at which safety and efficacy will be checked.

      Participants who withdraw prematurely will have a visit at withdrawal, 4 Weeks after
      withdrawal and then every 12 Weeks until 72 Weeks after baseline at which safety will be
      checked.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention description(s): Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TMC435 capsule is taken once daily for 12 weeks.
Intervention MeSH terms: Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435HPC3011; TMC435