Hepatitis C, Chronic, Liver Cirrhosis
Conditions
Brief summary
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.
Interventions
PegIntron administered at a dose of 1.5 ug/kg QW SC for up to 48 weeks
Rebetol administered at a dose of 600, 800, or 1000 mg/day, orally, for up to 48 weeks.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up | Measured at 24 weeks post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Rate of subject with undetectable HCV-RNA at the end of treatment (or at discontinuation of treatment) | Measured at the end of treatment (or at discontinuation of treatment) |
Outcome results
None listed