The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment
NCT ID: NCT05755776
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
204 participants
OBSERVATIONAL
2023-03-01
2024-12-31
Brief Summary
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* The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
* What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.
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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ETV group
Participants in this group will continue ETV daily until the end of the study.
No interventions assigned to this group
TMF group
Participants in this group will switch to TMF 25 mg, daily until the end of the study.
TMF
switch ETV to TMF
Interventions
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TMF
switch ETV to TMF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
3. Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
4. Subjects treated with ETV over 1 year will be able to be enrolled in the study.
5. Subjects with 20 ≤ HBV-DNA \< 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
6. Must be willing and able to comply with all study requirements.
Exclusion Criteria
2. Men and women of childbearing potential who are unwilling to use an "effective" method of contraception as defined in the protocol during the study period.
3. Co-infection with HAV HCV, HIV, HDV or HEV; or co-infection with autologous liver, metabolism-related fatty liver, or drug-induced liver injury.
4. Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellular carcinoma)
5. Patients who have received a solid organ or bone marrow transplant
6. History of malignancy within 5 years prior to screening, except for specific tumors cured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluated for probable malignancy were ineligible.
7. Currently receiving treatment with immunomodulators (e.g., corticosteroids), investigational drugs, nephrotoxic drugs, or drugs capable of regulating renal excretion. Drugs that modulate renal excretion.
8. Renal, cardiovascular, pulmonary, or neurological disease that is considered severe by the investigator.
9. Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesis imperfecta, chondromalacia) or multiple fractures.
10. Subjects receiving a contraindicated combination drug (subjects receiving a contraindicated drug require a minimum 30-day washout period) and known hypersensitivity reactions to study drugs, metabolites or formulation excipients.
11. Current alcohol or drug abuse that, in the investigator's judgment, may interfere with the subject's compliance with study requirements.
12. Any other clinical condition that, in the opinion of the investigator, would render the subject unsuitable for the study or unable to comply with the dosing requirements medical condition or prior treatment.
13. Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Principal Investigators
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Peng Hu, phD
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Chongqing Medical University
Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Central Hospital
Chongqing, , China
Affiliated Hospital of Guangxi Medical University
Guangxi, , China
Hepatobiliary disease of Jilin Province
Jilin, , China
The First People's Hospital of Yunnan Province
Kunming, , China
the Second People's Hospital of Yunnan Province
Kunming, , China
Nanjing Second Hospital
Nanjing, , China
The Second Hospital of Ningbo
Ningbo, , China
Shanghai East Hospital
Shanghai, , China
Shuguang Hospital, Shanghai, China.
Shanghai, , China
The Sixth People's Hospital of Shenyang
Shenyang, , China
The First People's Hospital of Taicang
Taicang, , China
The Fourth People's Hospital of Zibo
Zibo, , China
Countries
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Central Contacts
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Facility Contacts
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Xuan An
Role: primary
Minghua Su
Role: primary
Hui Chen
Role: primary
Jiawei Geng
Role: primary
Hui Li
Role: primary
Wei Ye
Role: primary
Airong HU
Role: primary
Lihong QU
Role: primary
Xuehua Sun
Role: primary
Xiaofeng Wu
Role: primary
Yonglan Pu
Role: primary
Gang Li
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HS-10234-A005
Identifier Type: -
Identifier Source: org_study_id
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