Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Condition: Genotype 1 Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Telaprevir; Pegylated-interferon-alfa-2a; Ribavirin
Intervention description: Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks; Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks; Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is < 75kg) or 1200mg (if participant's weight is >= 75kg) per day for 24 or 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1 chronic Hepatitis C; VX-950HPC3007; VX-950; Hepatitis C; Telaprevir; HCV

Summary:

      The purpose of this study is to determine the effectiveness, safety and tolerability of
      telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated
      interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced
      Russian participants with genotype 1 chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has genotype 1 chronic hepatitis C with HCV RNA level >1000 IU/mL

          -  Participant is either treatment-naïve and did not receive any previous treatment with
             any approved or investigational drug or drug regimen for the treatment of hepatitis C,
             or participant is treatment-experienced who did not achieve sustained virologic
             response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy
             (null-responder, partial-responder or viral relapse)

          -  Participant must have documentation of liver biopsy or fibroscan within 2 years before
             the screening visit or agree to have a biopsy or fibroscan within the screening period
             unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago
             prior to screening

          -  A female participant of childbearing potential and a nonvasectomized male participant
             who has a female partner of childbearing potential must agree to the use of 2
             effective methods of birth control from screening until 6 months (female participant )
             or 7 months (male participant) after the last dose of RBV

        Exclusion Criteria:

          -  Prior non-responder that is classified as a viral breakthrough participant

          -  Participant is infected or co-infected with HCV of another genotype than genotype 1

          -  Participant has history of decompensated liver disease or shows evidence of
             significant liver disease in addition to hepatitis C

          -  Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
             co-infection

          -  Participant has active malignant disease or history of malignant disease within the
             past 5 years (with the exception of treated basal cell carcinoma or hepatocellular
             carcinoma