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

This study is ongoing, but not recruiting participants.

First Received: November 8, 2007 Last Updated: May 20, 2009 History of Changes

Sponsored by:	TCM Biotech International Corp.
Information provided by:	TCM Biotech International Corp.
ClinicalTrials.gov Identifier:	NCT00556504

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: TCM-700C Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by TCM Biotech International Corp.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TCM-700C	Drug: TCM-700C 2 tablets thrice daily from the beginning and for a total of 48 weeks
2: Placebo Comparator Placebo	Drug: Placebo 2 tablets thrice daily from the beginning and for a total of 48 weeks

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556504

Locations

Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333

Sponsors and Collaborators

TCM Biotech International Corp.

Investigators

Principal Investigator:

I-Sheen Sheen, MD

Chang Gung Memorial Hospital

More Information

No publications provided

Responsible Party:	TCM Biotech International Corp. ( TCM Biotech International Corp. )
Study ID Numbers:	TCM-700-01-04, 96-EC-17-A-20-I1-0017
Study First Received:	November 8, 2007
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00556504 History of Changes
Health Authority:	United States: Food and Drug Administration; Taiwan (R.O.C.): Department of Health

Keywords provided by TCM Biotech International Corp.:

add-on treatment
botanical drug
HCV genotype 1
TCM-700C
genotype I

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on July 06, 2009