Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Percentage of patients who achieve normalization of ALT in each treatment group
研究概览
简要总结
In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:
- •At least 20 years of age and willing to sign an informed consent
- •Patients who can practice contraception
- •Patients who are classified either as relapsers or non-responders.
- •Weight between 45 and 100 kg
- •Patients willing to be hospitalized for 3 days after the start of treatment
- •Patients with positive HCV-RNA
- •Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
- •Neutrophil count: equal to or more than 1,200 /mm^3
- •Platelet count：equal to or more than 100,000/mm^3
排除标准
- •Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
研究组 & 干预措施
1.0 Dose Group
PegIntron 1.0 mcg/kg SC QW for 12 weeks
干预措施: PegIntron (peginterferon alfa-2b) (Biological)
0.25 Dose Group
PegIntron 0.25 mcg/kg SC QW for 12 weeks
干预措施: PegIntron (peginterferon alfa-2b) (Biological)
0.5 Dose Group
PegIntron 0.5 mcg/kg SC QW for 12 weeks
干预措施: PegIntron (peginterferon alfa-2b) (Biological)
No-treatment Control
No treatment (no placebo)
结局指标
主要结局
Percentage of patients who achieve normalization of ALT in each treatment group
时间窗: Measured at the end of 12 weeks of treatment or at discontinuation.
次要结局
- Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)(Measured between when the patient signs the informed consent form and the end of post-treatment follow-up)