EUCTR2007-007075-16-NL进行中（未招募）不适用
The effect of peroxisome proliferator activator receptor ? agonist pre-treatment on pegylated interferon-a2a and ribavirin efficacy in hepatitis C patients, previously resistant to treatment with pegylated interferon and ribavirin - a randomized-controlled trial - - HEPAR study
VU university medical center0 个研究点目标入组 50 人开始时间: 2008年7月11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
- 50
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
- •? CHC genotype 1 infected men and women = 21 and = 65 yrs of age
- •? Previously non-responders or relapsers to PEG-IFN and RBV containing treatment
- •? Previous resistance to antiviral therapy will be defined as:
- •- Decrease in PCR detected viral load of =2log in response to at least 12
- •weeks of treatment with PEG-IFN and RBV containing treatment
- •- Recurrence of HCV-RNA, previously undetectable after treatment of at
- •least 12 weeks with PEG-IFN and RBV containing treatment
- •(breakthrough and relapse)
- •? Patients requiring a liver biopsy before treatment
- •? Fasting plasma glucose =7.0 mmol/l
- •? Hepatic steatosis defined as increased hyperechogenicity on abdominal ultrasound and/or histological signs of steatosis (grade 0-3 according to the NASH clinical research network scoring system)
- •? Written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc)
- •Exclusion criteria for liver biopsy (bleeding tendency, extended bile ducts etc)
- •? ALT levels = 150 IU/ml
- •? Co-infection with HIV or hepatitis B
- •? Present excessive alcohol use defined as > 2 units/day
- •? Cardiovascular co-morbidity defined as heart failure, coronary insufficiency and hypertension in past history
- •? Any type of diabetes mellitus
- •? Use of glucocorticosteroids, hormonal substitution, pagitaxel, theofyllin, myelosuppresive agents.
- •? A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study
- •? Present abuse of i.v. drugs (including methadon)
- •? Subject no longer available for follow-up assessment
- •? Standard contraindication for treatment with PEG-IFN and RBV such as:
- •-Decompensated liver cirrhosis
- •-Pregnancy / breastfeeding
- •-Lack of appropriate contraception
- •-Expected non-compliance
研究者
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