An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Telaprevir; Pegylated-interferon-alfa-2a; Placebo; Ribavirin
Intervention description: Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.; Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.; Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.; Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; Telaprevir; Pegylated-interferon-alfa-2a; Pegasys; Ribavirin; Copegus

Summary:

      The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C
      Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is,
      pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with
      antiretroviral therapy) participants.
    

Eligibility criteria:

        Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

          -  Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000
             International unit per milliliter (IU/mL) at Screening

          -  Participant never received treatment for HCV

          -  Participant was to be in good health (besides HCV infection), in the opinion of the
             Investigator, judged on the basis of medical history and physical examination
             (including vital signs and screening electrocardiogram [ECG]), with any chronic
             medical conditions under stable medical control

          -  Participant had to be willing to refrain from the concomitant use of any medications
             or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis
             or history of suspicion of alcohol, barbiturate, or amphetamine recreational or
             narcotic drug use, which in the Investigator's opinion would compromise the
             participant's safety and/or compliance with study procedures

          -  Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
             co-infection

          -  Female participants who are pregnant, or planning to become pregnant, or
             breastfeeding, and partners of female participants who are pregnant or breastfeeding

          -  Participant has hypersensitivity to tartrazine

          -  Participant had participated in any clinical trial for an investigational drug within
             90 days before drug administration or participated in more than 2 drug studies in the
             last 12 months