Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
The objective of the study is to evaluate the superiority of treatment with PegIntron and
 Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and
 type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to
 Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron
 and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who
 have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and
 enter Follow-up.
Inclusion Criteria:

 Patients with compensated hepatic cirrhosis secondary to chronic hepatitis C who would meet
 all the inclusion criteria below and would not interfere with any of the exclusion criteria
 below.

 -  Patients (regardless of gender) who can take contraceptive measures from date of
 informed consent to the end of follow-up

 -  Patients who meet all the criteria below in the test/observation/ investigation in 30
 days before the beginning of treatment.

 -  Patients with quantitative HCV-RNA (+)

 -  ALT > 40 IU/L

 -  Patients who are classified as Child-Pugh Classification A, and who do not have
 ascites or hepatic encephalopathy

 -  Prothrombin Time <=3.0 seconds prolonged, total bilirubin <= 1.5 mg/dL or direct
 bilirubin <= 0.7 mg/dL, Albumin >= 3.0 g/dL

 -  AFP within normal limits, AFP-L3 <= 10%，PIVKA-II <= 100 mAU/mL

 -  Serum creatinine <= upper limit of normal, creatinine clearance >= 51 mL/minute

 -  Patients with fasting blood glucose < 110 mg/dL.

 -  Thyroid-stimulating hormone within normal limits

 -  Hemoglobin level >= 12 g/dL，leukocyte count >= 3,000/mm3，neutrophil count >=
 1,500 /mm3，platelet count >= 80,000/mm3

 -  Patients who weighs more than 40 kg and not more than 100 kg within 60 days prior to
 registration

 -  Patients who were diagnosed with liver cirrhosis (fibrosis score: F4) based on the
 liver biopsy performed within a year prior to registration and is able to provide with
 liver tissue sample.

 -  Patients who between the ages of 20 and 70 years at time of informed consent who can
 give written informed consent

 -  Patients who can be hospitalized at least for 14 days from the initiation of
 treatment.

 Exclusion Criteria:

 -  Patients who have been administered pegylated interferon or ribavirin in the past.

 -  Patients who had previously received treatment with IFN for whom at least 90 days have
 not elapsed since the end of previous treatment by the time of registration in the
 study

 -  Patients who have received treatment within 14 days prior to registration with the
 injectable preparations containing glycyrrhizin/cysteine/glycyron (Stronger
 Neo-Minophagen C, etc.), or shosaikoto

 -  Patients who have had antiviral drug or antitumor drug, or immune regulation therapy
 (including steroid administration, radiation therapy) within 90 days prior to
 registration. [except for topical application and external drug]

 -  Patients who have been administered any study drug within 180 days prior to
 registration.

 -  Patients who meet the following criteria in the screening test

 -  HBs antigen positive

 -  antinuclear antibody >= 320 times

 -  Patients with or who have a history of primary biliary cirrhosis, hepatic failure,
 hepatocellular carcinoma.

 -  Patients with other etiologies of liver disease such as autoimmune, alcoholic and
 drug-induced liver diseases

 -  Patients with or who have a history of decompensated cirrhosis with following
 disorder. Ascites, jaundice, bleeding varices, esophageal and/or gastric varices which
 needs treatment, hepatic encephalopathy, and spontaneous bacterial peritonitis.

 -  Patients with hemophilia

 -  Patients with or who have a history of neuropsychiatry disorder such as depression.

 -  Patients with or who have a history of epileptic seizures requiring treatment

 -  Patients with or who have a history of angina pectoris, heart failure, myocardial
 infarction, uncontrollable hypertension (diastolic blood pressure: equal to or more
 than 110mmHg) or arrhythmia which needs treatment.

 -  Patients with chronic pulmonary disease

 -  Patients with or who have a history of autoimmune disease (Crohn's disease, ulcerative
 colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic
 lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc).

 -  Patients with Hemoglobinopathies (thalassaemia, sickle cell anemia)

 -  Patients with malignant tumors

 -  Patients with organ transplants (other than cornea and hair transplant).

 -  Patients with a history of hypersensitivity to interferon preparations, biological
 products such as vaccine, or nucleoside analogs

 -  Female patients who are pregnant or nursing (male patients with partner who are
 pregnant), and for whom pregnancy cannot be ruled out by serum HCG test conducted
 during the screening period

 -  Patients with specific reaction to PEG-IFNα-2b in prick test conducted before the
 initiation of treatment（Only PEG/R group）

 -  Other patients judged by the investigator (sub-investigator) to be inappropriate for
 inclusion in this study