NL-OMON37588已完成不适用
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) - Peginterferon Add-on study in Chronich hepatitis B patients
Stichting Leveronderzoek0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- •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;
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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