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Not yet recruiting NCT05965388

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

— Observational HBV HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nucleoside analogues or interferon.
Who it may be relevant to
Registry conditions: HBV, HCC. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period [Time frame: 5 years]
Secondary outcome measures (4)
  • Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with malignancies other than hepatocellular carcinoma.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 10 centers
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • Jiangsu Province Hospital — Nanjing
  • the Affiliated Hosptial of Xuzhou Medical University — Xuzhou
  • Shandong Provincial Hospital of Shandong University — Jinan
  • The Third People's Hospital of Taiyuan — Taiyuan
  • First Affiliated Hospital Xi'an Jiaotong University — Xi’an
  • … and 2 more centers

Publications

  • 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

Identifiers

NCT: NCT05965388 · COMPASS by REASON

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗