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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TCM Biotech International Corp.
ClinicalTrials.gov Identifier:
NCT00556504
First received: November 8, 2007
Last updated: December 5, 2012
Last verified: December 2012
  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
Phase 2

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:


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 ]

Enrollment: 84
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: TCM-700C
TCM-700C, an add-on drug to conventional treatment of Hepatitis C
Drug: TCM-700C
An add-on drug to conventional treatment of Hepatitis C
Placebo Comparator: Placebo
Placebo

  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
Study First Received: November 8, 2007
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

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 April 23, 2014