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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMF treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Amibufenamide（TMF） | Drug | Once-daily oral dose of 25 mg TMF were maintained in all participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with HBV DNA with lower than in the central laboratory | The proportion of patients with HBV DNA lower than in the central laboratory at week(144+)240、week(144+)336 | week(144+)240、week(144+)336 |
| Proportion of subjects with ALT normalization rate |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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The proportion of patients with normal ALT |
| week (144+)96、week (144+)240、week (144+)336 |
| Proportion of Patients Achieving HBsAg loss，HBsAg conversion | The denominator of HBsAg loss was the number of HBsAg- positive patients at 144 weeks. The denominator of HBsAg seroconversion was the number of HBsAg positive and anti-HBs negative persons at 144 weeks. | week (144+)96、week (144+)240、week (144+)336 |
| Incidence of resistance mutation | Resistance detection when a virological breakthrough occurs | week (144+)96、week (144+)240、week (144+)336 |
| Progression of liver disease associated with HBV infection | The proportion of patients with new HCC, Decompensated liver cirrhosis, death related to Hepatitis B | week (144+)96、week (144+)240、week (144+)336 |
| Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio | The denominator of HBeAg loss was the number of HBeAg- positive patients at 144 weeks. The proportion of HBeAg seroconversion was the number of HBeAg positive and anti-HBs negative persons at 144 weeks. | week (144+)96、week (144+)240、week (144+)336 |
| Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD) | measured by dual energy x-ray absorptiometry(DXA) | week (144+)96、week (144+)240、week (144+)336 |
| Change from Baseline in Serum Creatinine | week (144+)96、week (144+)240、week (144+)336 |
| Change in HBV DNA from baseline | week (144+)96、week (144+)240、week (144+)336 |
| 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 | Shanghai Tong Ren Hospital | 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 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |