NCT01532843已完成4 期
Lowering 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)
Foundation for Liver Research4 个研究点 分布在 2 个国家目标入组 82 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Sustained response
研究概览
简要总结
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.
The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 treatment with either Entecavir (one of all 3 brands) or Tenofovir
- •ALT < 5x ULN
- •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
研究组 & 干预措施
PegIFN alfa-2b + nucleos(t)ide analogue
Active Comparator
Peginterferon alfa-2b 1.5 μg/kg per week s.c. for 48 weeks in addition to standard nucleos(t)ide analogue treatment
干预措施: PegIFN alfa-2b (Drug)
结局指标
主要结局
Sustained response
时间窗: at week 72
Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA \< 200 IU/mL
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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