Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
Condition: Hepatitis; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Filibuvir; Filibuvir; Placebo
Intervention description: 300 mg BID; 600 mg BID; BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir

Summary:

      The primary objective for this study is to determine if the addition of filibuvir to a
      standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the
      proportion of subjects who achieve a sustained viral response (SVR) compared to
      peginterferon/ribavirin (pegIFN/RBV) therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects at least 18 years of age.

          -  HCV seropositive.

          -  HCV RNA >10,000 IU/mL at screening.

          -  HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are
             not eligible.

          -  Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational
             anti-HCV agents).

          -  Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis
             classification. For those subjects with liver biopsy outside of the time window or for
             those subjects with no history of liver biopsy, a biopsy must be performed prior to
             randomization.

          -  Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis
             or 2) those subjects with AFP >50 and <100 ng/mL with no evidence of hepatocellular
             carcinoma. For those subjects with an ultrasound conducted outside the 6-month time
             window, an ultrasound must be performed prior to randomization.

        Exclusion Criteria:

          -  Co-infection with either HIV or HBV.

          -  Evidence of severe or decompensated liver disease.

          -  Subjects with liver disease unrelated to HCV infection.

          -  Pre-existing medical condition that makes the subject unsuitable for treatment with
             pegIFN/RBV therapy per product labeling.

          -  Laboratory abnormality at Screening that makes the subject unsuitable for treatment
             with pegIFN/RBV therapy per product labeling.

          -  Abnormal ECG suggestive of clinically significant cardiac disease or QTc>450msec.

          -  History of organ transplant.

          -  Contraindicated medications being taken by the subject at the time of randomization
             that must be continued during the study period, including potent CYP3A4 inhibitors,
             sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and
             CYP3A4 inducers.

          -  Active alcohol or substance abuse sufficient, in the Investigator's judgment, to
             prevent adherence to study medication and/or follow up.

          -  Pregnant or nursing females.

          -  Males whose female partner is pregnant.