Clinical trial NCT00556504: The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: add-on treatment
botanical drug
HCV genotype 1
TCM-700C
genotype I
Lead sponsor: TCM Biotech International Corp.
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Sustained Virologic Response (SVR)
timeFrame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Secondary outcomes:
measure: Virologic Response
timeFrame: at the end of combination drug treatment (up to 48 weeks)
measure: ALT Response
timeFrame: at the end of combination drug treatment (up to 48 weeks)
measure: Sustained ALT Response
timeFrame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
measure: Combined ALT and Virologic Response
timeFrame: at the end of combination drug treatment (up to 48 weeks)
measure: Immune Cell Normalization
timeFrame: at the end of combination drug treatment (up to 48 weeks)
measure: Immune Cell Normalization
timeFrame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: I-Sheen Sheen, MD
role: PRINCIPAL_INVESTIGATOR
References: