Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB

Summary

Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.

Conditions

• Hepatitis B, Chronic

Interventions

DRUG

Tenofovir Amibufenamide（TMF）

Once-daily oral dose of 25 mg TMF were maintained in all participants

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jinlin Hou, M.M · Nanfang Hospital, Southern Medical University

• Junqi Niu, MD · The First Hospital of Jilin University

• Guicheng Wu, MD · Chongqing University Affiliated Three Gorges Hospital

• Peng Hu, MD · The second affiliated hospital of chongqiong medical university

• Lvfeng Yao · Mengchao Hepatopiliary Hospital of Fujian Medical University

• Wenhong Zhang, MD · Huashan Hospital

• Minghua Su, MM · First Affiliated Hospital of Guangxi Medical University

• Xiaoqing Fu, MM · Hangzhou Xixi hospital

• Caiyan Zhao, MD · Third hospital of Hebei Medical University

• Jia Shang · Henan Provincial People's Hospital

• Xiaorong Mao, MD · LanZhou University

• Shufang Yuan, MD · LiuZhou People's Hospital

• Jie Li, MD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Qing Xie, MD · Ruijin Hospital

• Qin Zhang, MD · Tongren Hospital,Shanghai Jiao Tong University School of Medicine

• Desheng Xie, MM · Shanghai Fifth People's Hospital

• Liang Chen, MM · Shanghai Public Health Clinical Center

• Yao Xie, MD · Beijing Ditan Hospital

• Jidong Jia, MD · Beijing Friendship Hospital

• Enqiang Chen, MD · West China Hospital

• Xingxiang Yang, MM · Sichuan Academy of Medical Sciences

• Fengmei Wang, MD · Tianjin Third Central Hospital

• MingQin Lu, MM · The First Hospital of Wenzhou Medical University

• Lihua Sun, MD · First Affiliated Hospital of Xinjiang Medical University

• Daokun Yang, MM · First Affiliated Hospital of Xinjiang Medical University

• Xuebing Yan, MD · The Affiliated Hospital of Xuzhou Medical University

• Huazhong Chen, MM · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

• Min Zhang, MD · Central South University

• Yan Huang, MD · Xiangya Hospital of Central South University

• Yawen Luo, MM · Zunyi Medical College

• Lihua Zhong, MM · The Fourth Affiliated Hospital of Harbin Medical University

• Min Xie · Guangzhou Eighth People's Hospital

• Jun Li, MD · Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2024-06-30

Completion

2029-09-30

Countries

• China

Study Locations