Clinical trial NCT00686881: Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
Official title: A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 261
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Change in Metavir Fibrosis Score
timeFrame: Baseline and discontinuation of treatment (up to 156 weeks)
Secondary outcomes:
measure: Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
timeFrame: Week 24
measure: Number of Participants With Change in Metavir Inflammation Score
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
Study officials:
References: