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

• Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration [ Time Frame: Week 24 ]
  The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
• Number of Participants With Change in Metavir Inflammation Score [ Time Frame: Baseline and Week 48 ]
  Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).

• Improvement in hepatic enzymes [ Time Frame: At Week 24 from the start of treatment ]
• Improvement in liver inflammation [ Time Frame: At Week 48 from the start of treatment ]

• Biological: Peginterferon alfa-2b (PegIFN-2b)
  PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
  Other Names:

  • SCH 054031
  • Pegylated interferon alfa-2b
• Drug: Comparator: Stronger neo minophagen C (SNMC)
  SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

• Experimental: PegIFN-2b
  Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
  Intervention: Biological: Peginterferon alfa-2b (PegIFN-2b)
• Active Comparator: SNMC
  Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
  Intervention: Drug: Comparator: Stronger neo minophagen C (SNMC)

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

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

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