EUCTR2004-004736-30-DE进行中（未招募）不适用
Peginterferon alfa-2a and Ribavirin Combination Therapy in Patients with HBeAg-negative Chronic HBV Infection - PARC study
Foundation of Liver research0 个研究点目标入组 122 人开始时间: 2005年5月9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
- 122
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
- •- Chronic hepatitis B (HBsAg positive > 6 months)
- •- Biopsy performed within one year prior to screening or during screening
- •- ALT > 1.5 x ULN on two occasions within 2 months prior to randomization (normal ALT values in between are allowed)
- •- HBeAg negative, anti-HBeAg positive on two occasions within 2 months prior to randomization
- •- HBV DNA > 10E5 copies/ml (centrally measured by Taqman PCR within 28 days prior to randomization)
- •- Age 18-70 years
- •- Written informed consent
- •- Hepatic imaging (US, CT or MRI) without evidence of hepatocellular carcinoma within 3 months prior to randomization
- •- two forms ofAdequate contraception for males and females during treatment and follow up (written confirmation); negative pregnancy tests (for women of childbearing potential)
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
- •- Severe hepatitis activity as documented by ALT>10 x ULN
- •- Advanced liver disease
- •- Pre-existent leucopenia or thrombopenia
- •- Co-infection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
- •- Other acquired or inherited causes of liver disease
- •- Alpha fetoprotein > 50 ng/ml.
- •- Serum creatinine level > 1.5 times the upper limit of normal at screening or evidence of severe renal disease
- •- Hyper- or hypothyroidism (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)
- •- Other significant medical illness that might interfere with this study: significant cardiovascular or pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
- •- Immune suppressive treatment within the previous 6 months
- •- Women with ongoing pregnancy or breast-feeding
- •- Male partners of women who are pregnant
研究者
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