To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart
研究概览
简要总结
After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months,
- •ALT < ULN (Upper Limit Normal) on 2 or more occasions in last 6 months [ULN: 45]
- •HBV DNA >2000 IU/mL
- •Age > 18 years
排除标准
- •Decompensated Cirrhosis
- •Severe HBV flare with reactivation
- •Presentation as ACLF (Acute on Chronic liver Failure)
- •Baseline ALT > ULN (Upper Limit Normal)
- •Contraindications to PEG-IFN therapy
- •Prior HBV antiviral therapy within 6 months of enrollment
- •Co-infections with HCV/HIV
- •ANA +(autoantibodies suggestive of autoimmune disease) >1:80
- •Patient not willing for enrollment in the study
- •Pregnancy, lactation
- •Patients who leave the study/ discontinue the therapy before completion
研究组 & 干预措施
Tenofovir + Interferon alpha 2 b
干预措施: Tenofovir disoproxil Fumarate (Drug)
Tenofovir
干预措施: Tenofovir + Interferon alpha 2b (Drug)
结局指标
主要结局
Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart
时间窗: 65 weeks
次要结局
- HBsAg loss(64 weeks)
- Absence of quantifiable serum HBV DNA(64 weeks)
- Development of serious adverse effects, acute hepatitis or hepatic decompensation(64 weeks)