NCT01890200

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

A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Adding TCM-700C,Botanical Drug, on the Standard Treatment (Peginterferon and Ribavirin) for Subjects With Naive Genotype 1 Hepatitis C Infection

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: TCM Biotech International Corp. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects with written informed consent will be stratified according to their baseline HCV RNA (≤800,000 IU/mL versus\>800,000 IU/mL), stage of liver fibrosis (METAVIR system fibrosis score of 0 1 versus 2 3). During the 48 week Treatment Period and 24 week Follow up Period, subjects will be assessed at regular intervals for efficacy and safety at Weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. If possible, subjects who prematurely discontinue the study during the Treatment Period will have samples taken for hematology, biochemistry and urinalysis in the same week of discontinuation as well as 24 weeks after discontinuation.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2013-07-01
• Last updated: 2017-04-28

Locations

2 sites across 2 countries: China, Taiwan