drugset / Trial / NCT00556504

The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection

NCT00556504

Phase 2 Completed 84 enrolled TCM Biotech International Corp.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.

Timeline

Start
2007-07
Primary completion
2011-01
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject TCM-700C Traditional medicine (herbal / TCM) 2 unknown
Background Peginterferon alfa-2a Protein / enzyme biologic 1.5 ug/kg
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral