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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response (SVR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
TCM-700C
an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: TCM-700C (Drug)
TCM-700C
an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: Peginterferon alfa-2a (Drug)
TCM-700C
an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: Ribavirin (Drug)
Placebo
placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: Peginterferon alfa-2a (Drug)
Placebo
placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: Ribavirin (Drug)
Placebo
placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
干预措施: Placebo (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR)
时间窗: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment.. 1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72. 2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value. 3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable. Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)
次要结局
- Sustained ALT Response(24 weeks after the termination of combinational drug treatment (up to 72 weeks))
- Combined ALT and Virologic Response(at the end of combination drug treatment (up to 48 weeks))
- Virologic Response(at the end of combination drug treatment (up to 48 weeks))
- ALT Response(at the end of combination drug treatment (up to 48 weeks))
- Immune Cell Normalization(24 weeks after the termination of combinational drug treatment (up to 72 weeks))