Clinical trial NCT01200420 (phase 2, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: miravirsen, saline
SMILES: COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  BMI 18-38 kg/m2

          -  Treatment-naïve to interferon-alpha based therapies

          -  HCV genotype 1

          -  Clinical and laboratory findings consistent with a clinical diagnosis of CHC,
             including:

        Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks
        prior to enrollment, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote
        risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C

          -  Serum HCV RNA > 75,000 IU/mL at Screening

          -  (North American sites only). Liver biopsy within 36 months of Day 1, indicating the
             absence of cirrhosis

          -  Screening hematology, clinical chemistries, coagulation and urinalysis are not
             clinically significant and the following criteria are met:

          -  Platelets >100,000/mm3

          -  Total WBC > 3000/mm3 and ANC >1500/mm3

          -  Hemoglobin > 11 g/dL for females and > 12 g/dL for males

          -  Total and direct bilirubin, WNL (except for clearly documented Gilbert's Syndrome)

          -  ALT < 5 x ULN

          -  Serum creatinine WNL and creatinine clearance as calculated by the Cockcroft-Gault
             formula > 80 ml/min

          -  Negative results on the following Screening laboratory tests: urine or serum pregnancy
             test (for women of childbearing potential), hepatitis B surface antigen and human
             immunodeficiency virus (HIV) antibody.

          -  For men and women of childbearing potential, willingness to utilize adequate
             contraception and not become pregnant (or have their partner become pregnant) during
             the full course of the study. Adequate contraceptive measures include oral
             contraceptives (stable use for 2 or more cycles prior to Screening). IUD,
             Depo-Provera, Norplant System implants, bilateral tubal ligation, vasectomy, condom or
             diaphragm plus either contraceptive sponge, foam or jelly and abstinence.

        Exclusion Criteria:

          -  Other known cause of liver disease except for CHC

          -  History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including
             ascites, hepatic encephalopathy, esophageal variceal bleeding, fibrosis or other signs
             of hepatic insufficiency or portal hypertension

          -  History of hepatocellular carcinoma (HCC) on imaging studies or serum
             alpha-fetoprotein (AFP) > 50 ng/mL at Screening

          -  Concurrent clinically significant medical diagnosis (other than hepatitis C-related
             conditions) that would potentially interfere with the subjects study compliance or
             confound study results

          -  Concurrent social conditions (e.g. drugs, alcohol, transportation) which would
             potentially interfere with the subject's study compliance

          -  Clinically significant illness within 30 days preceding entry into the study

          -  Participated in an investigational drug study within 30 days or 5 half-lives,
             whichever is longer, prior to the start of study medication.