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

TCM Biotech International

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Placebo; Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: TCM-700C

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556504

TCM-700-01-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

84 participants in 2 patient groups, including a placebo group

TCM-700C

Experimental group

Description:

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

Treatment:

Drug: TCM-700C

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Drug: Placebo