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

NCT ID: NCT06743438

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2029-09-30

Brief Summary

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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.

Detailed Description

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Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.

Conditions

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Hepatitis B, Chronic

Keywords

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Hepatitis B, Chronic；HBV infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMF treatment group

Group Type EXPERIMENTAL

Tenofovir Amibufenamide（TMF）

Intervention Type DRUG

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

Interventions

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Tenofovir Amibufenamide（TMF）

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

Intervention Type DRUG

Other Intervention Names

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HS-10234

Eligibility Criteria

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Inclusion Criteria

* Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301

Exclusion Criteria

* 1\) Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2）Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.

4）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.

5）Known hypersensitivity to study drugs, metabolites, or formulation excipients.

6\) In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7）Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinlin Hou, M.M

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Junqi Niu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Guicheng Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Affiliated Three Gorges Hospital

Peng Hu, MD

Role: PRINCIPAL_INVESTIGATOR

The second affiliated hospital of chongqiong medical university

Lvfeng Yao

Role: PRINCIPAL_INVESTIGATOR

Mengchao Hepatopiliary Hospital of Fujian Medical University

Wenhong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Minghua Su, MM

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Guangxi Medical University

Xiaoqing Fu, MM

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Xixi hospital

Caiyan Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Third hospital of Hebei Medical University

Jia Shang

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Xiaorong Mao, MD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Shufang Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

LiuZhou People's Hospital

Jie Li, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Qing Xie, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Qin Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Tongren Hospital,Shanghai Jiao Tong University School of Medicine

Desheng Xie, MM

Role: PRINCIPAL_INVESTIGATOR

Shanghai Fifth People's Hospital

Liang Chen, MM

Role: PRINCIPAL_INVESTIGATOR

Shanghai Public Health Clinical Center

Yao Xie, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Jidong Jia, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Enqiang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Xingxiang Yang, MM

Role: PRINCIPAL_INVESTIGATOR

Sichuan Academy of Medical Sciences

Fengmei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Third Central Hospital

MingQin Lu, MM

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Wenzhou Medical University

Lihua Sun, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Daokun Yang, MM

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Xuebing Yan, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Huazhong Chen, MM

Role: PRINCIPAL_INVESTIGATOR

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Min Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Central South University

Yan Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Yawen Luo, MM

Role: PRINCIPAL_INVESTIGATOR

Zunyi Medical College

Lihua Zhong, MM

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of Harbin Medical University

Min Xie

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Eighth People's Hospital

Jun Li, MD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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HS-10234-401

Identifier Type: -

Identifier Source: org_study_id