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临床试验/NCT04242433
NCT04242433Unknown不适用

Patterns of Resistance-associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct Acting Antiviral Agents in the Public Health Setting

Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年7月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Achievement of sustained virological response

研究概览

简要总结

Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). Pre-existence of resistance associated substitutions (RASs) to direct antiviral agents (DAAs) reduces sustained virologic response (SVR) rates by 3-53% in hepatitis C virus (HCV) genotype 3 infected patients depending on different predictors and the DAA regimen used. This study will prospectively analyze data from the MukhMantri Punjab Hepatitis C Relief Fund (MMPHCRF) to determine the posttreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with daclatasvir-sofosbuvir or sofosbuvir-ledipasvirin patients with chronic HCV.

The study aims to assess the prevalence and effect of RASs on sustained virological response (SVR) rates in patients with treatment failure to a regimen containing sofosbuvir and ledipasvir/daclatasvir.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All viremic chronic hepatitis C

排除标准

  • People with disseminated malignancy, advanced cardiovascular, 18 pulmonary, or neurological disease with short life expectancy were not enrolled

研究组 & 干预措施

Viremic Person living with HCV

All persons enrolled in the MMPHCRF treatment programme are provided free of charge direct acting antiviral agents and followed up for outcomes.

干预措施: Direct Acting Antivirals (Drug)

结局指标

主要结局

Achievement of sustained virological response

时间窗: 12 weeks after treatment completion

SVR12

Assessment of RAS

时间窗: 12 weeks after treatment completion

12 weeks after treatment completion

次要结局

  • Assessment of RAS in treatment failures(12 weeks after treatment completion)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Radha K Dhiman

Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (2)

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