Clinical trial NCT06743438: Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Official title: Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B - a Multicenter, Open-label Follow-up Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, Chronic；HBV infection
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
timeFrame: week (144+)96
Secondary outcomes:
measure: The proportion of subjects with HBV DNA with lower than in the central laboratory
timeFrame: week(144+)240、week(144+)336
measure: Proportion of subjects with ALT normalization rate
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Proportion of Patients Achieving HBsAg loss，HBsAg conversion
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Incidence of resistance mutation
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Progression of liver disease associated with HBV infection
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Change from Baseline in Serum Creatinine
timeFrame: week (144+)96、week (144+)240、week (144+)336
measure: Change in HBV DNA from baseline
timeFrame: week (144+)96、week (144+)240、week (144+)336
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, M.M
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Junqi Niu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing University Affiliated Three Gorges Hospital
name: Guicheng Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The second affiliated hospital of chongqiong medical university
name: Peng Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mengchao Hepatopiliary Hospital of Fujian Medical University
name: Lvfeng Yao
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Wenhong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Minghua Su, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou Xixi hospital
name: Xiaoqing Fu, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Third hospital of Hebei Medical University
name: Caiyan Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Jia Shang
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Xiaorong Mao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LiuZhou People's Hospital
name: Shufang Yuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Jie Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Qing Xie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongren Hospital,Shanghai Jiao Tong University School of Medicine
name: Qin Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Fifth People's Hospital
name: Desheng Xie, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Public Health Clinical Center
name: Liang Chen, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Yao Xie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Jidong Jia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Enqiang Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Academy of Medical Sciences
name: Xingxiang Yang, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Third Central Hospital
name: Fengmei Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Wenzhou Medical University
name: MingQin Lu, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Lihua Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Daokun Yang, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Xuebing Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Huazhong Chen, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: Min Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital of Central South University
name: Yan Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zunyi Medical College
name: Yawen Luo, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fourth Affiliated Hospital of Harbin Medical University
name: Lihua Zhong, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Eighth People's Hospital
name: Min Xie
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)
name: Jun Li, MD
role: PRINCIPAL_INVESTIGATOR
References: