Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy

Обзор

The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B. Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.

Подробное описание

This study is a prospective, exploratory, multi-center, real-world study, with Huashan Hospital as the leading unit. The study includes patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment { including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy. The study only collects clinical data and serum samples, without imposing any additional intervention measures or affecting any relevant clinical decisions. The clinical data is collected from the patient's clinical follow-up examination data, without additional visits and auxiliary examinations. Sample collection During the necessary clinical examination and blood draw during the patient's treatment and follow-up, one additional serum separation tube (3ml) was drawn, without additional invasive examination for the patient. The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points.

Вмешательства

• Препарат nucleoside analogues or interferon
  ETV、TDF、TAF、TAF、IFN-a-2b

Первичные конечные точки

• Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period [Срок оценки: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
• Number of Participants with Diagnosis of participants with liver transplantation during the observation period [Срок оценки: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
• Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period [Срок оценки: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
• Number of Participants with Diagnosis of participants with serological response during the observation period [Срок оценки: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]

Критерии участия

Критерии включения

• CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;
• Age between 18-80 years, gender is not limited；
• Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy;
• Patient who reads and signs informed consent.

Критерии исключения

• Patients with malignancies other than hepatocellular carcinoma.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 10 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Jiangsu Province Hospital — Нанкин
• the Affiliated Hosptial of Xuzhou Medical University — Xuzhou
• Shandong Provincial Hospital of Shandong University — Цзинань
• The Third People's Hospital of Taiyuan — Taiyuan
• First Affiliated Hospital Xi'an Jiaotong University — Xi’an
• … и ещё 2 центра

Публикации

• Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28. PMID 26231459
• Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. [The guidelines of prevention and treatment for chronic hepatitis B (2019 version)]. Zhonghua Gan Zang Bing Za Zhi. 2019 Dec 20;27(12):938-961. doi: 10.3760/cma.j.issn.1007-3418.2019.12.007. Chinese. PMID 31941257
• Jung MC, Pape GR. Immunology of hepatitis B infection. Lancet Infect Dis. 2002 Jan;2(1):43-50. doi: 10.1016/s1473-3099(01)00172-4. PMID 11892495
• Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4. PMID 27374637
• Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5. PMID 26048673
• Pollicino T, Belloni L, Raffa G, Pediconi N, Squadrito G, Raimondo G, Levrero M. Hepatitis B virus replication is regulated by the acetylation status of hepatitis B virus cccDNA-bound H3 and H4 histones. Gastroenterology. 2006 Mar;130(3):823-37. doi: 10.1053/j.gastro.2006.01.001. PMID 16530522
• Ko C, Chakraborty A, Chou WM, Hasreiter J, Wettengel JM, Stadler D, Bester R, Asen T, Zhang K, Wisskirchen K, McKeating JA, Ryu WS, Protzer U. Hepatitis B virus genome recycling and de novo secondary infection events maintain stable cccDNA levels. J Hepatol. 2018 Dec;69(6):1231-1241. doi: 10.1016/j.jhep.2018.08.012. Epub 2018 Aug 22. PMID 30142426
• Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018 May 1;319(17):1802-1813. doi: 10.1001/jama.2018.3795. PMID 29715359

Идентификаторы

NCT: NCT05965388 · COMPASS by REASON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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