临床试验/NCT03123653

NCT03123653Unknown不适用

To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy

Institute of Liver and Biliary Sciences, India1 个研究点分布在 1 个国家目标入组 118 人开始时间: 2017年3月17日最近更新: 2020年2月5日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Institute of Liver and Biliary Sciences, India
入组人数: 118
试验地点: 1
主要终点: Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year
Study design:Prospective,Interventional (single arm study)
Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month
Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
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

•HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU

排除标准

•HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia

研究组 & 干预措施

Peg IFN 2b

Experimental

Peg IFN 2b 1.5mcg/kg once every week for 48 weeks.

干预措施: Peg IFN 2b (Drug)

结局指标

主要结局

Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha

时间窗: 6 months

次要结局

Loss of HBsAg after 48 weeks of PEG IFN alpha(48 weeks)
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN(48 weeks)
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy(1 year)

研究者

发起方

Institute of Liver and Biliary Sciences, India

申办方类型

Other

责任方

Sponsor

研究点 (1)

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