The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection - Full Text View

Sponsor:	TCM Biotech International Corp.
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 A 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
Study Completion Date:	May 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 TCM-700C	Drug: TCM-700C 2 tablets thrice daily from the beginning and for a total of 48 weeks
Placebo Comparator: 2 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)during last 6 months
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.
ClinicalTrials.gov Identifier:	NCT00556504 History of Changes
Other Study ID Numbers:	TCM-700-01-04, 96-EC-17-A-20-I1-0017
Study First Received:	November 8, 2007
Last Updated:	September 21, 2011
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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on February 12, 2012