EUCTR2011-002459-33-IT进行中（未招募）不适用
Boceprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1, either deemed Nonresponders to Peginterferon/Ribavirin or treatment-naives. - MEN_BOC
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点目标入组 240 人开始时间: 2011年9月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Menopausal females with previously documented CHC infection, either (A) relapser or with a >2log10 IU/ml HCV RNA decrease at week 12 in a previous PEG IFN/Ribavirin treatment or (B) naives; • Subject must have a liver biopsy within the last 2 years with histology consistent with CHC and no other etiology. • Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •For protocol (A), menopausal women with a null response (<2log10 IU/ml HCV RNA decrease at week 12) in a previous PEG IFN/Ribavirin treatment. •Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive). •Treatment with any investigational drug within 30 days of the randomization visit in this study. •Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study. •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. •Diabetic and/or hypertensive subjects with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality. •Pre-existing psychiatric condition(s). •Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes. •Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study. •Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible. •Subjects who had life-threatening serious adverse event (SAE) during screening period. •Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN) •Serum albumin < lower limit of normal (LLN) •Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain exceptions. •Serum creatinine >ULN of the laboratory reference. •Protocol-specified serum glucose concentrations. •Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range. •Anti-nuclear antibodies (ANA) >1:320.
研究者
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