Status:
TERMINATED
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 chr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00686881
Start Date
December 1 2006
End Date
February 1 2011
Last Update
April 6 2017
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