EUCTR2011-005607-32-NL进行中（未招募）不适用
OWERING VIRAL LOAD WITH NUCLEOS(T)IDE ANALOGUES PRIOR TO PEGINTERFERON ALFA-2B TREATMENT TO INCREASE SUSTAINED RESPONSE IN HBEAG-POSITIVE CHRONIC HEPATITIS B (PEGON-STUDY) - PEGO
Foundation for Liver Research0 个研究点目标入组 80 人开始时间: 2011年12月16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
- 80
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)
- •HBeAg positive, anti-HBe negative within 4 weeks prior to initiation of peginterferon alfa-2b
- •HBV DNA < 2000 IU/ml within one month prior to initiation of peginterferon alfa-2b after a minimum of 12 months nucleos(t)ide analogue treatment, except Telbivudine
- •Compensated liver disease
- •Age = 18 years and = 70 years
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with any investigational drug within 30 days of entry to this protocol
- •Treatment with Telbivudine
- •Severe hepatitis activity as documented by ALT>5 x ULN
- •History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
- •Pre-existent neutropenia (neutrophils ?1,500/mm3) or thrombocytopenia (platelets ?90,000/mm3)
- •Co-infection with hepatitis C virus or human immunodeficiency virus (HIV)
- •Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson’s disease or alpha-1 antitrypsin deficiency
- •Alpha fetoprotein > 50 ng/ml
- •Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
- •Immune suppressive treatment within the previous 6 months
- •Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
- •Pregnancy, breast-feeding
- •Other significant medical illness that might interfere with this study: significant 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)
- •Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
- •Substance abuse, such as alcohol (?80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
- •Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
研究者
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