NCT00883844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 - a Pilot Study
Foundation for Liver Research2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年4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
- 11
- 试验地点
- 2
- 主要终点
- Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL
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 65 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 one month prior to initiation of peginterferon alfa-2b
- •HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon 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 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
1
Experimental
Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks
干预措施: Nucleos(t)ide analogue treatment with a peginterferon add-on strategy (Drug)
2
Active Comparator
Continuation of Nucleos(t)ide analogue mono-therapy
干预措施: Nucleos(t)ide analogue treatment (Drug)
结局指标
主要结局
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL
时间窗: at week 72
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHBChronic Hepatitis BNCT01532843Foundation for Liver Research82
撤回
不适用
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B PatientsChronic Hepatitis BNCT01260610Institute of Liver and Biliary Sciences, India
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)chronic hepatitis B virus infection1001965410047438NL-OMON35145Erasmus MC, Universitair Medisch Centrum Rotterdam30
已完成
2 期
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI MonotherapyHIV InfectionsNCT00000831National Institute of Allergy and Infectious Diseases (NIAID)280
已完成
4 期
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B VirusHepatitis B InfectionChronic InfectionViremiaNCT01788371Hua Zhang700