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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

Hepatitis C, Chronic

Treatments

Drug: Comparator: Stronger neo minophagen C (SNMC)

Biological: Peginterferon alfa-2b (PegIFN-2b)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00686881

P04773

JPC-05-356-30

Details and patient eligibility

About

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.

Enrollment

261 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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