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The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

NCT01890200 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-04-28

No results posted yet for this study

Summary

This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection.

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 combination treatment, compared with the placebo add-on.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Peginterferon alfa-2a

conventional treatment of Hepatitis C

DRUG

Ribavirin

conventional treatment of Hepatitis C

DRUG

TCM-700C

An add-on drug to conventional treatment of Hepatitis C

DRUG

Placebo

Placebo, without acting ingredient.

Sponsors & Collaborators

  • TCM Biotech International Corp.

    lead INDUSTRY

Principal Investigators

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

  • Lai Wei, MD · Peking University People's 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
2015-06-30
Primary Completion
2018-03-31
Completion
2018-06-30

Countries

  • China
  • 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 NCT01890200 on ClinicalTrials.gov