Clinical Investigation of Erlotinib as an HCV Entry Inhibitor
关键词
抽象
日期
最后验证: | 05/31/2014 |
首次提交: | 04/08/2013 |
提交的预估入学人数: | 04/17/2013 |
首次发布: | 04/18/2013 |
上次提交的更新: | 06/13/2014 |
最近更新发布: | 06/16/2014 |
实际学习开始日期: | 04/30/2013 |
预计主要完成日期: | 04/30/2015 |
预计完成日期: | 04/30/2015 |
状况或疾病
干预/治疗
Drug: 1- Erlotinib
Drug: placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: 1- Erlotinib Erlotinib is a first class HCV entry inhibitor. In this study, Erlotinib will be administered in escalating doses in sequential patient cohorts for 14 days as follows:
Dose level (DL) 1 = 50 mg / day,
Dose level (DL) 2 = 100 mg / day, and
Dose level (DL) 3 = 150 mg / day .
Each Dose Level (DL) includes 4 patients (3 patients treated with Erlotinib and one patient treated with the Placebo). Dose escalation will proceed to the subsequent DL in the absence of DLT (dose-limiting toxicity) in 2 patients receiving Erlotinib. | Drug: 1- Erlotinib Erlotinib 50 mg tablet by mouth every day for 14 days,
Erlotinib 100 mg tablet by mouth every day for 14 days,
Erlotinib 150 mg tablet by mouth every day for 14 days, |
Placebo Comparator: placebo | Drug: placebo Placebo 50 mg tablet by mouth every day for 14 days,
Placebo 100 mg tablet by mouth every day for 14 days,
Placebo 150 mg tablet by mouth every day for 14 days, |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Chronic genotype 1b hepatitis C infection with detectable HCV RNA (> 1x104 UI/mL) - Naïve, relapser or non-responder to interferon with or without ribavirin - Weight > 45kg, BMI between 18 and 25 Kg/m2 who had a liver biopsy or liver FibroScan eliminating the presence of cirrhosis in the year before enrollment, - Non-smoker or occasional smoker ( ie < 3 cig/day) Exclusion Criteria: - HIV or HBV infection - Cirrhosis or Liver decompensation - Chronic liver disease non related to HCV |
结果
主要结果指标
1. Assessment of virologic response and short-term safety of Erlotinib in patients infected with HCV genotype 1b [14-day assessment study]
次要成果指标
1. Assessment of pharmacokinetics of Erlotinib in HCV-infected patients [14-day assessment study]
其他成果措施
1. Assessment of Erlotinib in HCV-infected patients and evaluation of drug resistance [14-day assessment study]