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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: Peginterferon alfa-2b (PegIFN-2b)
* Drug: Comparator: Stronger neo minophagen C (SNMC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PegIFN-2b<br>Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. | Biological: Peginterferon alfa-2b (PegIFN-2b)<br>* PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks<br>* Other names: Pegylated interferon alfa-2b;|
| Active Comparator: SNMC<br>Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks. | Drug: Comparator: Stronger neo minophagen C (SNMC)<br>* SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in Metavir Fibrosis Score | Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis). | Baseline and discontinuation of treatment (up to 156 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration | The ALT was judged to have been normalized when the ALT level was 35 IU/L or below. | Week 24 | 
| Number of Participants With Change in Metavir Inflammation Score | 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). | Baseline and Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C