Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b (PegIFN-2b); Comparator: Stronger neo minophagen C (SNMC)
Intervention description: PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks; SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: hepatitis C

Summary:

      The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b)
      monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in
      participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2
      and F3) who were previously treated with interferon. The trial will evaluate the effect of
      treatment on the progression of liver fibrosis, liver inflammation, and liver function.
      Treatment will be administered for up to 156 weeks with a 4-week follow-up.
    

Eligibility criteria:

        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