Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
Condition: Hepatitis C, Chronic; Liver Cirrhosis
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Peginterferon alfa-2b; Ribavirin
Intervention description: Administered at 1.0 µg/kg/week SC for 48 weeks; Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL; treatment duration is 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hepatitis C

Summary:

      The objective is to evaluate the efficacy and safety of combination therapy with
      peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks
      in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants
      who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment
      will be discontinued from therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 20-70 years.

          -  Positive quantitative serum HCV-RNA.

          -  Participants classified as A in Child-Pugh classification, and who do not have ascites
             or hepatic encephalopathy.

          -  Diagnosed with type C compensated liver cirrhosis based on liver biopsy performed
             within 3 years or latest celioscopy.

          -  Prolonged prothrombin time by <=3.0 sec.

          -  Participants and partners of participants willing to use adequate contraception during
             the course of the study.

          -  Participants who can be hospitalized for at least 14 days since treatment initiation.

          -  Weight >40 kg and <=100 kg

          -  Hematology laboratory results of:

               -  hemoglobin >=12 g/dL

               -  neutrophil count >=1,500/mm^3

               -  platelet count >=70,000/ mm^3

          -  Blood chemistry results of:

               -  albumin and direct bilirubin within normal limits

               -  alpha fetoprotein (AFP) within reference range

               -  AFP-L3<=10%

               -  Protein induced by vitamin K (PIVKA)-II <=100 mAU/mL

        Exclusion Criteria:

          -  Participants who did not previously respond virologically to combination therapy with
             interferon (including polyethylene glycol-modified interferon) and ribavirin

          -  Participants who had previously received treatment with interferon for whom at least
             90 days have not elapsed since the end of previous treatment

          -  Participants who have received treatment within 14 days prior to registration with
             injectable preparations containing glycyrrhizin/cysteine/glycyron or shosaikoto

          -  Participants who have received administration of drugs having antiviral, anti-tumor,
             or immuno-modulating effect (including glucocorticoids and radiation therapy) within
             90 days prior to registration (excluding local administration and topicals)

          -  Participants who have received other investigational drugs within 180 days prior to
             registration

          -  Hepatitis B surface (HBs) antigen positive

          -  Antinuclear antibody >=320 times

          -  Serum creatinine exceeding the upper limit of reference range

          -  Participants with fasting blood glucose >=110 mg/dL (participants with fasting blood
             glucose >=110 mg/dL and <126 mg/dL can be registered if their hemoglobin A1C (HbA1c)
             is <6.5%) [fasting blood glucose should be measured when participants are not
             receiving treatment for diabetes mellitus]

          -  Participants with any of the following: diabetes mellitus that requires treatment;
             thyroid function disorder not controlled by treatment; liver disease such as
             autoimmune, alcoholic and drug-induced liver diseases; hemophilia; arrhythmia
             requiring treatment; co-existing hypertension not controlled by drug therapy (systolic
             blood pressure [BP] >=160mmHg or diastolic BP>=100mmHg); chronic pulmonary disease;
             hemoglobinopathies (thalassemia, sickle cell anemia); malignant tumors or who have a
             history of malignant tumor within the past 5 years; organ transplants (other than
             cornea and hair transplant)

          -  Participants with or who have a history of primary biliary cirrhosis, liver failure,
             hepatic carcinoma; decompensated liver cirrhosis with any the following diseases:
             ascites, jaundice, variceal hemorrhage, esophageal or gastric varices requiring
             treatment, hepatic encephalopathy, and idiopathic bacterial peritonitis; depression or
             schizophrenia requiring treatment, or suicidal attempt or suicidal ideation; epileptic
             seizures requiring treatment; angina, cardiac failure, myocardial infarction, or
             life-threatening arrhythmia; autoimmune disease (Hashimoto's disease, Crohn's disease,
             ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura,
             systemic erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); hepatic
             carcinoma

          -  Participants with a history of hypersensitivity to interferon preparations, biological
             products such as vaccine, or nucleoside analogs, and those with specific reaction to
             pegylated interferon alfa-2b in the prick test conducted before the initiation of
             treatment

          -  Women who are pregnant or nursing as well as women for whom pregnancy cannot be ruled
             out by serum human chorionic gonadotropin (HCG) test conducted during the screening
             period. Male participants with partners who are pregnant.