CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
TCM-700C +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00556504
NCT00556504Phase 2Completed
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TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection

TCM Biotech International Corp.·interventional·Posted Nov 12, 2007·Updated Aug 7, 2014

In Brief

A Phase 2 clinical trial evaluating TCM-700C, Peginterferon alfa-2a, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 12, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.6 years ago

Interventions

TCM-700Cdrug

An add-on drug to conventional treatment of Hepatitis C

Peginterferon alfa-2adrug

conventional treatment of Hepatitis C

Ribavirindrug

conventional treatment of Hepatitis C

Placebodrug

Placebo, without acting ingredient.