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| Name | Class |
|---|---|
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | INDUSTRY |
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The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:
Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.
Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETV group | Participants in this group will continue ETV daily until the end of the study. | ||
| TMF group | Participants in this group will switch to TMF 25 mg, daily until the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMF | Drug | switch ETV to TMF |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48. | Undetectable HBV DNA is defined as below 20 IU/mL. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24. | Undetectable HBV DNA is defined as below 20 IU/mL. | 24 weeks |
| The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48. |
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Inclusion Criteria:
Exclusion Criteria:
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The target population was chronic hepatitis B patients with LLV (HBV DNA from 20-to 2000IU/mL) of ETV treatment from multiple centers across mainland China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wu | Contact | +86 18652100702 | wuj6@hspharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Hu, phD | The Second Affiliated Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30992636 | Background | Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019 Mar 1;97(3):230-238. doi: 10.2471/BLT.18.219469. Epub 2019 Jan 28. | |
| 16391218 | Background | Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73. doi: 10.1001/jama.295.1.65. |
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There are two criteria for ALT normalization. Criteria1: below 40 U/L. Criteria2: Males: ALT<30U/L, female: ALT<19U/L.
| 24 weeks and 48 weeks |
| Comparing pgRNA levels from baseline at week 24 and 48. | 24 weeks and 48 weeks |
| Comparing HBcrAg levels from baseline at week 24 and 48. | 24 weeks and 48 weeks |
| The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48. | Undetectable pgRNA is defined as below 100 pg/mL. | 24 weeks and 48 weeks |
| The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48. | 24 weeks and 48 weeks |
| Comparing degree of liver fibrosis from baseline at week 24 and 48. | Evaluation of liver fibrosis including Fibroscan, APRI and FIB-4. | 24 weeks and 48 weeks |
| Comparing the change of creatinine clearance rate from baseline at week 24 and 48. | 24 weeks and 48 weeks |
| The types, incidence and severity of adverse events and serious adverse events during treatment were evaluated in both groups | Week 48 |
| Chongqing University Three Gorges Central Hospital | Not yet recruiting | Chongqing | 400010 | China |
|
| Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Guangxi | China |
|
| Hepatobiliary disease of Jilin Province | Not yet recruiting | Jilin City | China |
|
| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | China |
|
| the Second People's Hospital of Yunnan Province | Not yet recruiting | Kunming | China |
|
| Nanjing Second Hospital | Not yet recruiting | Nanjing | China |
|
| The Second Hospital of Ningbo | Recruiting | Ningbo | China |
|
| Shanghai East Hospital | Recruiting | Shanghai | China |
|
| Shuguang Hospital, Shanghai, China. | Not yet recruiting | Shanghai | China |
|
| The Sixth People's Hospital of Shenyang | Not yet recruiting | Shenyang | China |
|
| The First People's Hospital of Taicang | Not yet recruiting | Taicang | China |
|
| The Fourth People's Hospital of Zibo | Not yet recruiting | Zibo | China |
|
| 29405329 | Background | Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available. |
| 32147592 | Background | Sun Y, Wu X, Zhou J, Meng T, Wang B, Chen S, Liu H, Wang T, Zhao X, Wu S, Kong Y, Ou X, Wee A, Theise ND, Qiu C, Zhang W, Lu F, Jia J, You H. Persistent Low Level of Hepatitis B Virus Promotes Fibrosis Progression During Therapy. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2582-2591.e6. doi: 10.1016/j.cgh.2020.03.001. Epub 2020 Mar 6. |
| 28012257 | Background | Kim JH, Sinn DH, Kang W, Gwak GY, Paik YH, Choi MS, Lee JH, Koh KC, Paik SW. Low-level viremia and the increased risk of hepatocellular carcinoma in patients receiving entecavir treatment. Hepatology. 2017 Aug;66(2):335-343. doi: 10.1002/hep.28916. Epub 2016 Dec 24. |
| 29113914 | Background | Wang J, Sheng Q, Ding Y, Chen R, Sun X, Chen X, Dou X, Lu F. HBV RNA virion-like particles produced under nucleos(t)ide analogues treatment are mainly replication-deficient. J Hepatol. 2018 Apr;68(4):847-849. doi: 10.1016/j.jhep.2017.10.030. Epub 2017 Nov 4. No abstract available. |
| 21364549 | Background | Yuen MF, Seto WK, Fung J, Wong DK, Yuen JC, Lai CL. Three years of continuous entecavir therapy in treatment-naive chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety. Am J Gastroenterol. 2011 Jul;106(7):1264-71. doi: 10.1038/ajg.2011.45. Epub 2011 Mar 1. |
| 31185710 | Background | Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for management of chronic hepatitis B. Clin Mol Hepatol. 2019 Jun;25(2):93-159. doi: 10.3350/cmh.2019.1002. Epub 2019 Jun 12. No abstract available. |
| 32304611 | Background | Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30. |
| 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. |
| 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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