NCT00047814已完成2 期
A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 18
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.
详细描述
This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following criteria is a brief summary of Criterion required for trial participation.
- •Inclusion Criteria
- •Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy
- •Has positive HCV RNA by RT-PCR
- •Has abnormal ALT levels (at least 2 X ULN)
- •Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation
- •Has normal liver function indicated by: PT =< 2 sec. prolonged compared to the ULN, Albumin >= 3.5 g/dL, Total bilirubin =< 1.5 mg/dL
- •ANA titer =< 1:160
排除标准
- •Has positive skin test for tuberculosis
- •Has ALT value >= 300 IU/L
- •Has abnormal hematological parameters indicated by: ANC < 1500/mm3 and Platelets < 100,000/mm3
- •Has creatinine > 1.5 X ULN
- •AFP > 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound
- •Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies
研究者
研究点 (18)
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