NL-OMON35145已完成3 期
owering viral load with nucleos(t)ide analogues prior to peg-interferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PADD-study) - PEG-IFN in HBV patients with an incomplete response to NA-therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
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 one month prior to initiation of peg-interferon alfa-2b
- •· HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peg-interferon alfa-2b
- •· Compensated liver disease
- •· Age > 18 years
- •· Written informed consent
排除标准
- •· Treatment with any investigational drug within 30 days of entry to this protocol
- •· Severe hepatitis activity as documented by ALT>10 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 <1,800/mm3) or thrombocytopenia (platelets <90,000/mm3)
- •· Co-infection with hepatitis C virus, hepatitis D 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 PEG-interferon 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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