NL-OMON31787撤回不适用
The effect of peroxisome proliferator activator receptor * agonist pre-treatment on pegylated interferon-*2a and ribavirin efficacy in hepatitis C patients, previously resistant to treatment with pegylated interferon and ribavirin - a randomized-controlled trial - - HEPAR Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* CHC genotype 1 infected men and women * 21 and * 65 yrs of age
- •* Previously non-responders or relapsers to any PEG-IFN-containing treatment
- •* Patients requiring a liver biopsy before treatment
- •* Fasting plasma glucose *7.0 mmol/l
- •* Hepatic steatosis
- •* Written informed consent
排除标准
- •* Exclusion criteria for MRI
- •* ALT levels * 150 IU/ml
- •* Co-infection with HIV or hepatitis B
- •* Present excessive alcohol use defined as > 2 units/day
- •* Cardiovascular co-morbidity
- •* 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
研究者
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