Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C Read More

Inclusion Criteria:

• Patients with chronic hepatitis C previously treated with interferon
• At least 20 years of age
• Liver fibrosis score rated as F2 or F3 based on the result of liver biopsy at screening
• Female patients willing to use contraception
• Body weight from 35.0 kg to 110.0 kg (inclusive)
• Positive for hepatitis C virus ribonucleic acid (HCV-RNA) by qualitative assay

• Patients who meet the following laboratory criteria:

  • Serum alanine aminotransferase (ALT) level: >60 IU/L
  • Neutrophil count: >=1,200/mm^3
  • Platelet count: >=100,000/mm^3
  • Serum potassium level: >=3.5 mEq/L

Exclusion Criteria:

• Patients who received interferon therapy within 90 days of Screening
• Patients who have received antiviral agents or antitumor agents, or immunomodulator therapy (including chronic glucocorticoids and radiotherapy) within 90 days of Screening (excluding local administration and topical use)
• Patients who have received other investigational drugs within 90 days of Screening
• Hepatitis B surface antigen (HBs)positive
• Antinuclear antibody titer of 1:320 or higher
• Creatinine level exceeding the upper limit of the reference range measured at screening test 2;
• Fasting blood glucose level of >=126 mg/dL
• Patients on insulin therapy regardless of the fasting blood glucose level
• Patients who have a concurrent or past history of any of the following conditions: liver cirrhosis, liver failure, or liver carcinoma; hepatic encephalopathy, esophageal varices requiring treatment, or ascites; suicidal attempt or ideation; epileptic seizures requiring drug therapy; angina pectoris, heart failure, myocardial infarction or fatal arrhythmia; autoimmune disease (Hashimoto's disease [chronic thyroiditis], Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); malignant tumors (it is permitted to register patients with at least 5 years after cure).
• Patients who concurrently have any of the following conditions: liver disease such as autoimmune hepatitis, alcoholic liver injury, and drug-induced hepatitis; hemophilia; depression or schizophrenia which requires treatment; hypertension which cannot be controlled by drug therapy or arrhythmia which requires treatment, chronic pulmonary disease; abnormal thyroid function that cannot be controlled by drug therapy; organ transplants (other than corneal, hair transplant, etc.); aldosteronism, myopathy, or hypokalemia.
• Patients with a history of hypersensitivity to interferon preparations or biological products such as vaccines
• Patients with a history of hypersensitivity to monoammonium glycyrrhizinate, glycine, or L-cysteine monohydrochloride;
• Women who are pregnant or lactating, and women in whom pregnancy cannot be ruled out based on the result of serum human chorionic gonadotropin (HCG) measurement at Screening