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

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ClinicalTrials.gov Identifier: NCT05965388
Recruitment Status : Not yet recruiting
First Posted : July 28, 2023
Last Update Posted : July 28, 2023
Sponsor:
Collaborators:
Shandong Provincial Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Fujian Medical University
The Third People's Hospital of Taiyuan
The First People's Hospital of Yunnan
The First Affiliated Hospital of Anhui Medical University
Wuhan Union Hospital, China
The First Affiliated Hospital with Nanjing Medical University
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
HBV HCC Drug: nucleoside analogues or interferon

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : February 1, 2029
Estimated Study Completion Date : February 1, 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic hepatitis B patients treated with nucleoside analogues or interferon
Chronic hepatitis B patients treated with nucleoside analogues or interferon
 Drug: nucleoside analogues or interferon
ETV、TDF、TAF、TAF、IFN-a-2b


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period [ Time Frame: 5 years ]
    Number of Participants with Diagnosis of hepatocellular carcinoma


Secondary Outcome Measures :
  1. 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 decompensation cirrhosis

  2. 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 liver transplantation

  3. 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 fibrosis regression and progression

  4. 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 ]
    Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg


Biospecimen Retention:   Samples Without DNA
Collect the serum samples of CHB patients receiving antiviral therapy during long-term follow-up, and detect the concentration of HBV pgRNA in the samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05965388


Contacts
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Contact: Wenhong Zhang, MD 13801844344 zhangwenhong@fudan.edu.cn

Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Contact: Ying Ye    13856980361    yeying2@139.com   
China, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
Contact: Yuekai Hu, M.D.    13564579738    746896522@qq.com   
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
the Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Contact: Xuebing Yan, M.D.    15205215685    yxbxuzhou@126.com   
China, Shandong
Shandong Provincial Hospital of Shandong University
Jinan, Shandong, China
Contact: Wanhua Ren       ganbingzx@163.com   
China, Shanxi
The Third People's Hospital of Taiyuan
Taiyuan, Shanxi, China
Contact: Ying Guo         
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shanxi, China, 710061
Contact: Yingli He, M.D.    18991232863    heyingli2000@mail.xjtu.edu.cn   
China, Yunnan
The First People's Hospital Of YunNan
Kunming, Yunnan, China, 650100
Contact: Jiawei Geng, M.D.    13888757766    746896522@qq.com   
China
Huashan Hospital
Shanghai, China, 200040
Contact: Wenhong Zhang, Professor    13801844344    zhangwenhong@fudan.edu.cn   
Contact: Feng Sun, doctor    15921403893    aaronsf1125@126.com   
Sponsors and Collaborators
Wen-hong Zhang
Shandong Provincial Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Fujian Medical University
The Third People's Hospital of Taiyuan
The First People's Hospital of Yunnan
The First Affiliated Hospital of Anhui Medical University
Wuhan Union Hospital, China
The First Affiliated Hospital with Nanjing Medical University
More Information
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Publications:

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Responsible Party: Wen-hong Zhang, Director of Division ofInfectious Diseases Affiliation: Huashan Hospital, Huashan Hospital
ClinicalTrials.gov Identifier: NCT05965388    
Other Study ID Numbers: COMPASS by REASON
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
 DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents