Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase
NCT ID: NCT05661786
Last Updated: 2022-12-22
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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RECRUITING
4500 participants
OBSERVATIONAL
2022-12-31
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation cohort
Observation
Monitor every 6 months
Treatment cohort
Antiviral treatment
Receive first-line antiviral treatment, including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide or peginterferon
Interventions
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Observation
Monitor every 6 months
Antiviral treatment
Receive first-line antiviral treatment, including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide or peginterferon
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. Treatment-naïve
4. HBeAg negative, anti-HBe positive
5. HBV DNA \>2000 IU/mL
6. Persistently normal alanine transaminase (ALT)
7. Liver inflammation \<G2 or A2 and liver fibrosis \<S2 or F2 before enrollment, or liver stiffness \>8 kilopascals (kPa)
8. No family history of liver cirrhosis or hepatocellular carcinoma
Exclusion Criteria
2. Coexisting of hepatocellular carcinoma and other malignancy, or alpha-fetoprotein \>upper limit of normal at enrollment;
3. Presence of liver cirrhosis;
4. Alcohol abuse within the last year (ethanol: male \>40 g/d, female \>20 g/d; or heavy drinking within 2 weeks before enrollment: ethanol \>80 g/d), or history of drug abuse;
5. Participating in other clinical trials in the last 3 months;
6. Coexisting of autoimmune liver diseases;
7. Pregnant or planned pregnancy in a short term or lactation patients;
8. History of severe heart disease, mental disease;
9. Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
10. Neutrophil count \<2×10\^9/L and/or platelet count \<100×10\^9/L;
11. History of organ transplantation or preparing for organ transplantation;
12. Using immunosuppressive drugs;
13. Undergone organ transplantation or preparing for organ transplantation;
14. Receiving immunosuppressive agents;
15. Patients thought by the investigators not suitable to participate in this study.
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Chao Wu
Principal Investigator
Locations
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The Third Hospital of Changzhou
Changzhou, Jiangsu, China
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Suqian People's Hospital
Suqian, Jiangsu, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Longgen Liu
Role: primary
Weimao Ding
Role: primary
Chao Wu, M.D., Ph.D.
Role: primary
Rui Huang, M.D., Ph.D.
Role: backup
Huaping Shao
Role: primary
Chuanwu Zhu
Role: primary
References
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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.
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.
Huang DQ, Li X, Le MH, Le AK, Yeo YH, Trinh HN, Zhang J, Li J, Wong C, Wong C, Cheung RC, Yang HI, Nguyen MH. Natural History and Hepatocellular Carcinoma Risk in Untreated Chronic Hepatitis B Patients With Indeterminate Phase. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1803-1812.e5. doi: 10.1016/j.cgh.2021.01.019. Epub 2021 Jan 16.
Yao K, Liu J, Wang J, Yan X, Xia J, Yang Y, Wu W, Liu Y, Chen Y, Zhang Z, Li J, Huang R, Wu C. Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone. J Viral Hepat. 2021 Jul;28(7):1025-1033. doi: 10.1111/jvh.13511. Epub 2021 Apr 26.
European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
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.
Bonacci M, Lens S, Marino Z, Londono MC, Rodriguez-Tajes S, Mas A, Garcia-Lopez M, Perez-Del-Pulgar S, Sanchez-Tapias JM, Forns X. Anti-viral therapy can be delayed or avoided in a significant proportion of HBeAg-negative Caucasian patients in the Grey Zone. Aliment Pharmacol Ther. 2018 May;47(10):1397-1408. doi: 10.1111/apt.14613. Epub 2018 Mar 25.
Choi GH, Kim GA, Choi J, Han S, Lim YS. High risk of clinical events in untreated HBeAg-negative chronic hepatitis B patients with high viral load and no significant ALT elevation. Aliment Pharmacol Ther. 2019 Jul;50(2):215-226. doi: 10.1111/apt.15311. Epub 2019 May 28.
Other Identifiers
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NJDTID-2201
Identifier Type: -
Identifier Source: org_study_id