A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in
      combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the
      proportion of patients with sustained virologic response at Week 72 (patients with
      undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and
      at Week 72), compared to the control group receiving PegIFN and RBV in combination with
      TMC435-matched placebo.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither
      investigator nor the participant knows the treatment that the participant receives),
      placebo-controlled (an inactive substance that is compared with the study medication to test
      whether the study medication has a real effect in clinical study) study to compare the
      efficacy, tolerability and safety of different TMC435 regimens combined with peginterferon
      alfa-2a (PegIFNα-2a) and ribavirin (RBV) versus PegIFNα-2a plus RBV alone in adult
      treatment-naive patients with chronic genotype 1 HCV infection. The study mainly consists of
      3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and
      follow up phase (up to 48 weeks). In the treatment phase, patients will be divided in to 5
      different arms in a 1:1:1:1:1 randomized ratio. In treatment arms 1 and 2, patients will
      receive 12 weeks of therapy with TMC435 along with PegIFNα 2a and RBV followed by treatment
      with PegIFNα 2a, RBV, and TMC435-matched placebo. In treatment arms 3 and 4, patients will
      receive 24 weeks of therapy with TMC435, PegIFNα 2a, and RBV. In treatment arm 5 (control
      group), patients will receive PegIFNα 2a and RBV for 48 weeks and TMC435 matched placebo for
      the first 24 weeks. Collection of blood samples for efficacy evaluations will be done at
      scheduled visits throughout the study. Safety evaluations for adverse events, clinical
      laboratory tests, physical examination, vital signs and electrocardiogram will be monitored
      throughout the study. The total duration of the study will be up to approximately 72 weeks
      after initiation of treatment.
    

Intervention name(s): TMC435; Ribavirin (R); PegIFNα-2a (P); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.; Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.; PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.; Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
Other intervention name(s): TMC 435; COPEGUS; PEGASYS
Intervention MeSH terms: Ribavirin; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435; Peginterferon alpha-2a; PegIFNalpha-2a; RBV; Ribavirin; Placebo