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

NCT ID: NCT00556504

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-05-31

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

This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs >800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.

During the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TCM-700C

an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C

Group Type: EXPERIMENTAL

TCM-700C

Intervention Type: DRUG

An add-on drug to conventional treatment of Hepatitis C

Peginterferon alfa-2a

Intervention Type: DRUG

conventional treatment of Hepatitis C

Ribavirin

Intervention Type: DRUG

conventional treatment of Hepatitis C

Placebo

placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C

Group Type: PLACEBO_COMPARATOR

Peginterferon alfa-2a

Intervention Type: DRUG

conventional treatment of Hepatitis C

Ribavirin

Intervention Type: DRUG

conventional treatment of Hepatitis C

Placebo

Intervention Type: DRUG

Placebo, without acting ingredient.

Interventions

TCM-700C

An add-on drug to conventional treatment of Hepatitis C

Intervention Type: DRUG

Peginterferon alfa-2a

conventional treatment of Hepatitis C

Intervention Type: DRUG

Ribavirin

conventional treatment of Hepatitis C

Intervention Type: DRUG

Placebo

Placebo, without acting ingredient.

Intervention Type: DRUG

Other Intervention Names

Peg-INTRON, Schering-Plough; Rebetol, Schering-Plough)

Eligibility 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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TCM Biotech International Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Sheen Sheen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

TCM-700-01-04

Identifier Type: -

Identifier Source: org_study_id