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

Phase 3

Terminated

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: Peginterferon alfa-2b (PegIFN-2b)

• Registration Number: NCT00686881
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-03
• Results First Submitted QC: 2012-02-03
• Results First Posted: 2012-03-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 261

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PegIFN-2b	Peginterferon alfa-2b (PegIFN-2b)	Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change in Metavir Fibrosis Score	Baseline and discontinuation of treatment (up to 156 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration	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	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).