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

NCT06743438 | Active Not Recruiting Phase 4

• 1 other identifier: HS-10234-401
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatitis B, Chronic；HBV infection

Outcome Measures

Primary Outcomes (1)

• Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory

  The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.

  week (144+)96

Secondary Outcomes (9)

• The proportion of subjects with HBV DNA with lower than in the central laboratory

  week(144+)240、week(144+)336

• Proportion of subjects with ALT normalization rate

  week (144+)96、week (144+)240、week (144+)336

• Proportion of Patients Achieving HBsAg loss，HBsAg conversion

  week (144+)96、week (144+)240、week (144+)336

• Incidence of resistance mutation

  week (144+)96、week (144+)240、week (144+)336

• Progression of liver disease associated with HBV infection

  week (144+)96、week (144+)240、week (144+)336

Study Arms (1)

TMF treatment group

EXPERIMENTAL

Drug: Tenofovir Amibufenamide（TMF）

Interventions

Tenofovir Amibufenamide（TMF） DRUG

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

Also known as: HS-10234

TMF treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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.
• ）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
• ）Known hypersensitivity to study drugs, metabolites, or formulation excipients.
• \) 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinlin Hou, M.M

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Junqi Niu, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Guicheng Wu, MD

  Chongqing University Affiliated Three Gorges Hospital

  PRINCIPAL INVESTIGATOR

• Peng Hu, MD

  The second affiliated hospital of chongqiong medical university

  PRINCIPAL INVESTIGATOR

• Lvfeng Yao

  Mengchao Hepatopiliary Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Wenhong Zhang, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Minghua Su, MM

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

• Xiaoqing Fu, MM

  Hangzhou Xixi hospital

  PRINCIPAL INVESTIGATOR

• Caiyan Zhao, MD

  Third hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Jia Shang

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaorong Mao, MD

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Shufang Yuan, MD

  LiuZhou People's Hospital

  PRINCIPAL INVESTIGATOR

• Jie Li, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Qing Xie, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Qin Zhang, MD

  Tongren Hospital,Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Desheng Xie, MM

  Shanghai Fifth People's Hospital

  PRINCIPAL INVESTIGATOR

• Liang Chen, MM

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

• Yao Xie, MD

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

• Jidong Jia, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Enqiang Chen, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Xingxiang Yang, MM

  Sichuan Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Fengmei Wang, MD

  Tianjin Third Central Hospital

  PRINCIPAL INVESTIGATOR

• MingQin Lu, MM

  The First Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Lihua Sun, MD

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

• Daokun Yang, MM

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

• Xuebing Yan, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

• Huazhong Chen, MM

  Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Min Zhang, MD

  Central South University

  PRINCIPAL INVESTIGATOR

• Yan Huang, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Yawen Luo, MM

  Zunyi Medical College

  PRINCIPAL INVESTIGATOR

• Lihua Zhong, MM

  The Fourth Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Min Xie

  Guangzhou Eighth People's Hospital

  PRINCIPAL INVESTIGATOR

• Jun Li, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 19, 2024
• Study Start: March 10, 2022
• Primary Completion: June 30, 2024
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)