临床试验/NCT02591277

NCT02591277已完成不适用

A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection

Gilead Sciences0 个研究点目标入组 3,294 人开始时间: 2015年11月30日最近更新: 2019年2月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Gilead Sciences
入组人数: 3,294
主要终点: Incidence of adverse drug reaction (ADR) under real world settings

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记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

研究设计

研究类型: Observational
观察模型: Ecologic Or Community
时间视角: Prospective

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

•Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
•Patients who are prescribed Harvoni

排除标准

•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Harvoni

Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.

干预措施: Harvoni (Drug)

结局指标

主要结局

Incidence of adverse drug reaction (ADR) under real world settings

时间窗: Up to 16 weeks

次要结局

Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)(Posttreatment Weeks 12 and 24)
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks(Approximately 12 weeks after treatment completion or discontinuation)

研究者

发起方

Gilead Sciences

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus InfectionHepatitis C Virus Infection

NCT02537379Gilead Sciences552

已完成

不适用

A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)Infertility, Female

NCT01408615Organon and Co472

撤回

不适用

A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino PatientsHuman Immunodeficiency Virus-Type 1

NCT01726348Janssen Pharmaceutica

已完成

不适用

Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus InfectionHepatitis C

NCT02562742Gilead Sciences554

已完成

3 期

Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV TreatmentHIV-1 InfectionHCV Infection

NCT02707601Gilead Sciences150