The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection - Tabular View

Tracking Information

First Received Date ^ICMJE

November 8, 2007

Last Updated Date

May 20, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sustained Virologic Response (SVR) [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Sustained Virologic Response (SVR) [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ]

Change History

Complete list of historical versions of study NCT00556504 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Virologic response Alanine amino transferase (ALT) response Normalization of immune cells Relapse rate Safety [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: TCM-700C
Drug: Placebo

Study Arms / Comparison Groups

Experimental: TCM-700C
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HCV strain confirmed as genotype I;
Elevated ALT (≥1.5 x upper limit of normal)
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;

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00556504

Responsible Party

TCM Biotech International Corp., TCM Biotech International Corp.

Study ID Numbers ^ICMJE

TCM-700-01-04, 96-EC-17-A-20-I1-0017

Study Sponsor ^ICMJE

TCM Biotech International Corp.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

I-Sheen Sheen, MD

Chang Gung Memorial Hospital

Information Provided By

TCM Biotech International Corp.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP