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临床试验/NCT03090035
NCT03090035已完成3 期

Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses in Chronic Hepatitis C Treatment

Sheikh Zayed Medical College1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
98
试验地点
1
主要终点
Treatment Success rate

研究概览

简要总结

Objective:

Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection. This study was conducted to find out the frequency of different IL-28B (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 & 3) infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response (SVR).

Methods:

In this non-randomized observational study, ninety eight (98) patients with diagnosis of chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in standard doses for 24 weeks. End treatment response, sustained virological response, and relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860) polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.

详细描述

INTRODUCTION:

Hepatitis C virus (HCV) is a major health problem that effects nearly 170 million people worldwide [1, 2]. According to a report, about 64-103 million people are suffering from chronic HCV infection [3] and this chronic infection results in liver scarring, hepatocellular carcinoma or end-stage liver disease in about forty thousand (40,000) patients every year [4, 5]. According to WHO, liver disease initiated by chronic hepatitis C infection is responsible for more than 35 thousand deaths and 3 to 4 million people are infected every year[3, 6]. Hepatitis C Virus has been classified into seven genotypes and several subtypes, which are associated with distinct forms of geographic dispersal [7, 8]. The success of HCV treatment is affected by many viral, treatment or host factors.

Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection. Sustained virological response (SVR) rate with this treatment in HCV-2 & 3 has been reported to be 58-84% in previously untreated patients [9]. SVR can be affected by liver cirrhosis, hepatocellular carcinoma, ethnicity, age, gender and obesity. [10, 11] It has been clarified by some studies that interleukin-28B has an important role in the treatment success of HCV infection and IL-28B CC genotype is associated with 2 folds higher sustained virological response (SVR) as compared to CT and TT genotype [12-14]. The aim of present study was to find out the frequency of different IL28B (rs12979860) genotypes in patients with chronic hepatitis C (genotype type 2 or 3) infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response (SVR).

METHODS:

This non-randomized observational study was conducted in Sheikh Zayed Medical College/Hospital Rahim Yaar Khan. A total of ninety eight (98) patients with diagnosis of chronic hepatitis C genotype 2 or 3 were involved in this study. The duration of study was from January 2015 to January 2016. People living in Rahim Yaar Khan City belongs to different ethinic backgrounds because this city is located at the junction of three provinces of Pakistan (total provinces are four), so people residing here represent the whole Pakistani population living in different provinces. Institutional ethical approval was taken before starting this research work. A written informed consent was taken from every patient before including him/her in this study.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diagnosis of chronic hepatitis C genotype 2 or 3

排除标准

  • Patients with hepatitis genotype I and IV

研究组 & 干预措施

chronic hepatitis C genotype 2 or 3

Experimental

In all patients Pegylated Interferon α2 (pegIFN) plus Ribavirin were given in standard doses. Peg-INF was given in a dose of 180 μg/week and ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 & 3

干预措施: Pegylated Interferon α2 (Drug)

chronic hepatitis C genotype 2 or 3

Experimental

In all patients Pegylated Interferon α2 (pegIFN) plus Ribavirin were given in standard doses. Peg-INF was given in a dose of 180 μg/week and ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 & 3

干预措施: Ribavirin (Drug)

结局指标

主要结局

Treatment Success rate

时间窗: after 24 weeks of treatment

Treatment Success rate (End Treatment Response) was noted to check the adequency of treatment

次要结局

  • Sustained Virological Response(After 48 weeks of treament)
  • Relapse Rate(After 48 weeks of treament)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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