drugset / Trial / NCT00787371
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |