EUCTR2006-001243-55-ES进行中（未招募）不适用
Open, multicenter, phase IV study to evaluate the safety and effectiveness of peginterferon alfa-2a (40 KD) associated with ribavirin for the treatment chronic hepatitis C with persistent normal ALT in HIV coinfected patients
Miguel Santin Cerezales0 个研究点目标入组 230 人开始时间: 2006年6月14日最近更新:
适应症
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
- 230
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
- All
入选标准
- •Serologic evidence of chronic hepatitis C
- •Detectable RNA-HCV plasmatic levels
- •Patients with at least 5 ALT determinations in the usual limits
- •Serologic evidence of HIV-1 infection: Elisa and western-blot
- •Stable status of HIV-1 infection.
- •Stable HAART treatment patients unless 6 weeks before the basal evaluation
- •No HAART therapy patients unless 6 weeks after the initiation of the study
- •Negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Child-Pugh>6
- •Previous or signs of decompensated hepatic disease
- •DdI therapy
- •Signs of chronic hepatic disease, not due to HCV
- •Hepatocarcinome documented suspect
- •Neutrophyles<1500
- •Haemoglobine<11 in women or <12 in men
- •Platelets<70000
- •Severe Psiquiatric disease
- •Evidence of alcohol or drugs consumption
研究者
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