A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; Placebo; Peginterferon (PegIFNα-2a); Ribavirin
Intervention description: TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.; Placebo capsules identical in appearance to TMC435 capsules taken orally (by mouth) once daily for 28 days.; One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFNα-2a on Days 1, 8, 15, and 22; 200-mg tablets of ribavirin (body-weight adjusted dose) taken orally (by mouth) twice daily for 21 or 28 days in Cohorts 1 and 2 and for 28 days in Cohorts 4 and 5.
Intervention MeSH terms: Ribavirin; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Tibotec; TMC435350-TiDP16-C201; TMC435350-C201; TMC435; PEGASYS (peginterferon alpha-2a, PegIFNα-2a); COPEGUS (ribavirin)

Summary:

      The purpose of this study is to investigate how efficient TMC435350 will work against the
      Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and
      what the concentrations of TMC435350 in the blood are with or without pegylated interferon
      alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.
    

Eligibility criteria:

        Inclusion Criteria: - Documented chronic genotype 1 Hepatitis C infection - Able to comply
        with the protocol requirements and having good accessible veins - Amount of virus in the
        blood (HCV RNA) >= 10.000 IU/mL, at screening - Bodyweight as defined by a Quetelet Index
        (Body Mass Index [BMI]) between 18 and 32 kg/m², extremes included Exclusion Criteria: -
        Evidence of liver cirrhosis or decompensated liver disease or any other form of non-viral
        hepatitis - Participants receiving or having received treatment with polymerase inhibitor
        or protease inhibitor, or Standard of Care therapy with COPEGUS (ribavirin) and PEGASYS
        (peginterferon alpha-2a) for treatment for HCV during the 6 months before screening - Male
        participants with female partners of childbearing potential not agreeing to use a reliable
        birth control method, Female, except if postmenopausal for over 2 years, or
        posthysterectomy, or post-tubal ligation (without reversal operation) - History or evidence
        of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use,
        which would compromise the participant 's safety and/or compliance. A positive urine drug
        test at screening. Urine will be tested to check the current use of amphetamines, cocaine,
        and opioids (with the exclusion of methadone) - Participants having at least one lab
        toxicity that is found to be clinically significant - Participants co-infected with HIV, or
        Hepatitis A or B, or hepatitis B surface antigen, or active tuberculosis at screening,
        participants with prolonged QTc (>480 ms) value or any cardiac disease at screening, or any
        active clinically significant disease (e.g., cardiac dysfunction, cardio(myo)pathy, cardiac
        insufficiency), or medical history or physical examination findings during screening that,
        in the Investigator's opinion, would compromise the outcome of the trial - Participants
        having uncontrolled/unstable diabetes, epilepsy, a manifest psychiatric disease, non-stable
        methadone (or equivalent drug) use or participants having any other unstable disease,
        participants enrolled in another clinical trial within 90 days prior to screening