临床试验/CTRI/2025/06/088308

CTRI/2025/06/088308尚未招募不适用

Assessment of Early Seroconversion by Accelerated Hepatitis B Vaccination in advanced CKD patients- A Randomised Control Study

Dr Nandhini Devi1 个研究点分布在 1 个国家目标入组 130 人开始时间: 2025年6月15日最近更新: 2025年6月4日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 130
试验地点: 1
主要终点: The primary outcome of the study was the seroconversion rate at 12 weeks after the first dose of vaccination.

研究概览研究设计入排标准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

The study aims to assess the early seroconversion of accelerated Hepatitis B vaccination compared to the standard vaccination regimen in patients with advanced CKD.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•1.Patients aged 18 years and above.
•2.Patients with advanced CKD with eGFR less than 15 ml/min per 1.73m
•3.Patients not vaccinated with Hepatitis B vaccine earlier.

排除标准

•1.Patients with a history of HBV infection.
•2.Patients positive for HBsAg. 3.Patients positive for HIV.
•4.Recent H/O intake of immunosuppressive drugs.
•5.History of allergic adverse effects to other vaccines.

结局指标

主要结局

The primary outcome of the study was the seroconversion rate at 12 weeks after the first dose of vaccination.

时间窗: The primary outcome of the study was the seroconversion rate at 12 weeks after the first dose of vaccination.

次要结局

未报告次要终点

研究者

发起方

Dr Nandhini Devi

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Dr Nandhini Devi R

Stanley Medical College

研究点 (1)

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