慢性B型肝炎患者におけるエンテカビルからテノホビルジソプロキシルフマル酸塩への切り替えに関する研究
基本情報
- NCT ID
- NCT03258710
- 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
- 75
- 治験依頼者名
- GlaxoSmithKline
概要
Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen \[HBeAg\])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.