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

NCT00556504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-08-07

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

TCM-700C

An add-on drug to conventional treatment of Hepatitis C

DRUG

Peginterferon alfa-2a

conventional treatment of Hepatitis C

DRUG

Ribavirin

conventional treatment of Hepatitis C

DRUG

Placebo

Placebo, without acting ingredient.

Sponsors & Collaborators

  • TCM Biotech International Corp.

    lead INDUSTRY

Principal Investigators

  • I-Sheen Sheen, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556504 on ClinicalTrials.gov