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
Intervention: TMC435; TVR
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 771.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435HPC3001; TMC435; Hepatitis C Virus (HCV); HEP C; Genotype 1; Treatment experienced; Null responders; Partial responders

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have had a liver biopsy before screening (or between the screening and
             baseline visit), unless patient cannot undergo such a procedure or has evidence of
             portal hypertension not associated with cirrhosis. For patients who had a liver biopsy
             performed more than 2 years prior to screening or without a biopsy (because of a
             contraindication or portal hypertension), a non-invasive staging assessment needs to
             be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or
             FibroTest/FibroSure and must not be older than 6 months prior to screening

          -  Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the
             following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6
             months prior to the screening visit and/or presence of fibrosis on biopsy

          -  Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at
             screening)

          -  Patient must have had at least 1 documented previous course of treatment with
             PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for
             null responder and 20 weeks for partial responder)

        Exclusion Criteria:

          -  Hepatic decompensation (impaired functioning of the liver), as indicated by
             significant laboratory abnormalities or other active diseases

          -  Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C

          -  Liver disease not related to hepatitis C infection

          -  Previous chronic hepatitis C treatment, other than PegIFN and RBV