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| Name | Class |
|---|---|
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a multicenter, randomized, open, blank controlled trial ,in order to evaluate the effectiveness and safety of Amibufenamide(TMF) in the treatment of chronic hepatitis B virus infection patients with normal ALT .
Although the indications for antiviral therapy for patients with chronic hepatitis B have been gradually expanded in different guidelines, antiviral treatment efficacy remains unclear among patients with alanine aminotransferase (ALT) < 1 upper limits of normal (ULN). This study aimed to evaluate the the effectiveness and safety of TMF for these patients.
Tenofovir amibufenamide (TMF; codename: HS-10234), another formulation of tenofovir, shared the same ProTide technology as tenofovir alafenamide, which can provide more efficient intracellular delivery than TDF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMF treatment group | Experimental | TMF 25mg QD, from baseline to 240 weeks |
|
| Blank control group | No Intervention | No antiviral therapy is given. If ALT>2 ULN (40 IU/L) for HBeAg-positive patients or > ULN for HBeAg-negative patients during the study period, blank control group can be switched to TMF treatment once a day, 25mg/ time orally until the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Amibufenamide(TMF) | Drug | TMF, 25mg QD, from baseline to 240 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL | The primary efficacy endpoint was the proportion of patients with HBV DNA < 20 IU/mL at week 48 | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation the change from Baseline in HBV DNA | Change from baseline in HBV DNA | Week 48,Week 96,Week 144,week 240 |
| Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;
Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage) or liver stiffness over 9kpa measured by TE.
Abnormal hematological and biochemical parameters, including:
Hemoglobin < 10 g/dl Absolute neutrophil count < 0.75 × 10^9/L Platelets ≤ 50 × 10^9/L AST > 10 × ULN Total Bilirubin > 2.5 × ULN Albumin < 3.0 g/dL INR > 1.5 × ULN (unless stable on anticoagulant regimen) eGFR<50mL/min
Received solid organ or bone marrow transplant.
Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc).
Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
Complicated with uncontrollable cardiovascular and cerebrovascular diseases.
Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 30 days,Known hypersensitivity to study drugs, metabolites, or formulation excipients.
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital, Central South University | Changsha | Hunan | China | |||
| Beijing You'An Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34587302 | Background | Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29. | |
| 40937079 |
| Label | URL |
|---|---|
| Related Info | View source |
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The subjects were randomly divided into two groups. One group received TMF treatment for 48 weeks. Aonther group received no antiviral therapy and served as a blank control.
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Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss
| Week 48,Week 96,Week 144,Week 240 |
| Evaluation the proportion of Patients Achieving HBsAg Seroconversion | Proportion of patients achieving HBsAg seroconversion | Week 48,Week 96, Week 144, Week 240 |
| Evaluation the proportion of Patients Achieving HBeAg Seroconversion | Proportion of patients achieving HBeAg seroconversion | Week 48,Week 96,Week 144, Week 240 |
| Evaluation the proportion of Patients Achieving HBeAg Loss | Proportion of patients Achieving HBeAg Loss | Week 48,Week 96,Week 144 ,Week 240 |
| Evaluation the change from Baseline in HBsAg | Change from baseline in HBsAg | Week 48,Week 96,Week 144,Week 240 |
| Evaluation the percentage of Participants with resistance | Percentage of participants with resistance | Week 48,Week 96,Week 144,Week 240 |
| Evaluation the change from Baseline in liver fibrosis | Change from baseline in liver fibrosis | Week 48,Week 96,Week 144,Week 240 |
| Evaluation the proportion of Patients with get hepatitis acute attack(ALT >5 ULN (40 IU/L)) | Proportion of patients with get hepatitis acute attack(ALT >5 ULN (40 IU/L)) | Week 48,Week 96,Week 144,Week 240 |
| Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL | Week 96,Week 144,Week 240 |
| Evaluation the change from Baseline in Bone biomarker(β-CTX and P1NP) | Week 48,Week 96,Week 144,Week 240 |
| Evaluation the change from Baseline in sCR | Week 48,Week 96,Week 144,Week 240 |
| AE ,SAE | Week 48,Week 96,Week 144,Week 240 |
| The proportion of subjects with liver-related events | Liver decompensation, acute-on-chronic liver failure, hepatocellular carcinoma, liver transplantation, all-cause mortality | Week 48,96,144,192,240 |
| Beijing |
| China |
| People's Hospital of Dongyang City | Dongyang | China |
| Fuyang Second People's Hospital | Fuyang | China |
| The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province | Hangzhou | China |
| LiShui People's Hospital of Zhejiang Province | Lishui | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| Jiangsu Province Hospital | Nanjin | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. | Shanghai | China |
| Shanghai East Hospital | Shanghai | China |
| The Fifth People's Hospital of Suzhou | Suzhou | China |
| The Fifth People's Hospital of Wuxi | Wuxi | China |
| Result |
| Gui H, Shen Y, Tan L, Hu P, Qian F, Wu X, Qiu Y, Zheng S, Lv J, Shi Y, Li J, Jiang Y, Hu Z, Nie F, Huo Y, Qu L, Xie Q. Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study. J Clin Transl Hepatol. 2025 Jul 28;13(7):568-577. doi: 10.14218/JCTH.2025.00162. Epub 2025 Jun 30. |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| 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 |
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