drugset / Trial / NCT00787371

Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

NCT00787371

Phase 2 Completed 69 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.

Timeline

Start
2005-06
Primary completion
2006-07
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 0.25 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 0.5 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 1 ug/kg Subcutaneous