Clinical trial NCT00154869 (phase 3, status: unknown status)
Conditions: hepatitis b, chronic, hepatitis c, chronic
ICD codes: B18.0, B18.1, B18.2, B18.8, B18.9, B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: peginterferon alfa-2a plus ribavirin
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients >= 18 years of age will be recruited.

          -  Patients with dual chronic hepatitis C and B must be positive for both anti-HCV and
             HBsAg for more than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS
             AMPLICOR HCV MONITOR® Test version 2.0).

          -  Patients must not be positive for HBeAg.

          -  Patients with monoinfected chronic hepatitis C must be positive for anti-HCV for more
             than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS AMPLICOR HCV
             MONITOR® Test version 2.0). Patients must not be positive for HBsAg.

        All patients must:

          -  Be treatment naïve for the hepatitis disease or have had treatment failure to previous
             interferon monotherapy or treatment failure to previous lamivudine therapy.

          -  Present with elevated serum ALT levels at least 1.5 times the upper limit of normal,
             documented on two occasions (at least one month apart), within six months prior to
             enrollment

          -  Present with liver biopsy findings compatible with the diagnosis of chronic liver
             disease (the liver biopsy needs to be taken within 52 weeks prior to the first dose of
             study drug)

          -  Have adequate liver reserve (defined as equal to or better than Child-Pugh Class A)

          -  Present with WBC 3500/mm3, ANC 1500/mm3, and platelets 90,000/mm3

        Exclusion Criteria:

          -  Be drug addicts or have any history or histological evidence of alcohol abuse, or
             currently receive prescriptions that may cause hepatotoxicity

          -  Present with hemoglobin <12.0 gm/dl for females and <13.0 gm/dl for males

          -  Signs or symptoms of hepatocellular carcinoma

          -  Any investigational drug ? 6 weeks prior to the first dose of study drug

          -  Have renal insufficiency (serum creatinine concentration >1.5 x upper limit of normal
             at screening; upper limit depending on lab at each site)

          -  Patients with documented or presumed coronary artery disease or cerebrovascular
             disease should not be enrolled if, in the judgment of the investigator, an acute
             decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin
             therapy) would not be well-tolerated.

          -  Have serological evidence of autoimmune chronic liver disease (e.g. antinuclear
             antibody titers > 1:320, and/or smooth muscle antibody titers > 1:160)

          -  History of major organ transplantation with an existing functional graft

          -  History or other evidence of severe illness, malignancy or any other conditions which
             would make the patient, in the opinion of the investigator, unsuitable for the study

          -  Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)

          -  Evidence of severe retinopathy (e.g., CMV retinitis, macular degeneration) or
             clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension

          -  Have been exposed to hepatotoxic substances which might be the cause of hepatitis

          -  Be pregnant, lactating or not practicing two adequate forms of birth control, such as
             oral contraceptives or intrauterine devices

          -  Be seropositive for anti-HIV or anti-delta or anti-HAV IgM Ab

          -  History of severe psychiatric disease, especially depression, characterized by a
             suicide attempt, hospitalization for psychiatric disease, or a period of disability as
             a result of psychiatric disease

          -  Have AFP (alpha-fetoprotein) greater than 20 ng/ml; in case of elevated AFP, abdomen
             ultrasonography is required to exclude the possibility of HCC.

          -  History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial
             infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment,
             unstable angina or other significant cardiovascular diseases).

          -  Have a history of asthma (see above) or drug allergy which may lead to the
             hypersensitivity to ribavirin

          -  Male partners of women who are pregnant