A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B

Summary

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.

Timeline

Start

2017-10-02

Primary completion

2018-12-28

Completion

2019-11-25

Publications

• Suzuki F, Suzuki Y, Karino Y, Tanaka Y, Kurosaki M, Yatsuhashi H, Atarashi T, Atsukawa M, Watanabe T, Enomoto M, Kudo M, Maeda N, Kohno H, Joko K, Michitaka K, Miki K, Takahashi K, Ide T, Fujiyama S, Kohno T, Itoh H, Tsukamoto S, Suzuki Y, Kawano Y, Sugiura W, Kumada H. Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study. BMC Gastroenterol. 2021 Dec 20;21(1):489. doi: 10.1186/s12876-021-02008-9.

Drugs

Indications