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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TCM Biotech International Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• HCV strain confirmed as genotype I;

• Elevated ALT (≥1.5 x upper limit of normal)during last 6 months

• Females of childbearing potential with a negative serum pregnancy test

• Subject must be willing to sign a written informed consent

• Subject must be willing and able to adhere to dose and visit schedule.

Exclusion Criteria:

• Serum AFP levels > 400 ng/ml

• Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);

• Co-infection with hepatitis B virus (HBV);

• Anti-HIV positive;