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グラゾプレビルとエルバスビルを併用したCKD-3のG1b慢性C型肝炎患者を対象とした研究

基本情報

NCT ID
NCT03144635
ステータス
完了
試験のフェーズ
第4相
試験タイプ
介入
目標被験者数
80
治験依頼者名
Kyushu University

概要

The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are metabolized in the liver and do not require dose-adjustment for patients with renal dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir treatment for Japanese elderly patients with renal dysfunction (eGFR\<60 mL/min/1.73m2) have been reported. Therefore, physicians are at a loss whether or not to treat the patients with renal dysfunction due to no evidence. The aim of this study is to investigate the improvement of serum endostatin level of Japanese patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A replication complex inhibitor) treatment by a prospective, multicenter cohort study.

対象疾患

Hepatitis C ViralChronic Kidney Disease stage3

介入

Grazoprevir plus Elbasvir(DRUG)

依頼者(Sponsor)

実施施設 (1)

九州大学病院

Fukuoka, Japan