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Published in: Trials 1/2020

Open Access 01-12-2020 | Hepatitis B | Study protocol

Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multi-center, double-blind, randomized controlled trial in China

Authors: Xiaoke Li, Ludan Zhang, Mei Qiu, Yi Huang, Huanming Xiao, Bingjiu Lu, Yuyong Jiang, Fuli Long, Hui Lin, Jinyu He, Qikai Wu, Mingxiang Zhang, Li Wang, Xiaoning Zhu, Man Gong, Xuehua Sun, Jianguang Sun, Fengxia Sun, Wei Lu, Weihua Xu, Guang Chen, Zhiguo Li, Danan Gan, Xianzhao Yang, Hongbo Du, Yong’an Ye

Published in: Trials | Issue 1/2020

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Abstract

Background

Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal.

Methods/design

The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial.

Conclusion

This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population.

Trial registration

Chinese Clinical Trial Registry No. ChiCTR1900021232​. Registered on February 2, 2019
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Metadata
Title
Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multi-center, double-blind, randomized controlled trial in China
Authors
Xiaoke Li
Ludan Zhang
Mei Qiu
Yi Huang
Huanming Xiao
Bingjiu Lu
Yuyong Jiang
Fuli Long
Hui Lin
Jinyu He
Qikai Wu
Mingxiang Zhang
Li Wang
Xiaoning Zhu
Man Gong
Xuehua Sun
Jianguang Sun
Fengxia Sun
Wei Lu
Weihua Xu
Guang Chen
Zhiguo Li
Danan Gan
Xianzhao Yang
Hongbo Du
Yong’an Ye
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04417-9

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