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

July 20, 2023 updated by: Wen-hong Zhang

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • The First Affiliated Hospital Of Fujian Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Province Hospital
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hosptial Of XuZhou Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital of Shandong University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • The Third People's Hospital of Taiyuan
        • Contact:
          • Ying Guo
      • Xi'an, Shanxi, China, 710061
    • Yunnan
      • Kunming, Yunnan, China, 650100
        • The First People's Hospital of Yunnan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
Time Frame: 5 years
Number of Participants with Diagnosis of hepatocellular carcinoma
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 liver transplantation
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 fibrosis regression and progression
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
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
Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wen-hong Zhang

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Anhui Medical University
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital Xi'an Jiaotong University
Wuhan Union Hospital, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
The Affiliated Hospital of Xuzhou Medical University
The First People's Hospital of Yunnan
The Third People's Hospital of Taiyuan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPASS by REASON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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