Actively Recruiting

Age: 18Years - 65Years
All Genders
ID05977283

An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-02-20

100

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study follows adults with chronic hepatitis B who have experienced a decline in HBsAg levels within the past 12 months. The research aims to describe treatment patterns and assess their impact on HBsAg loss, regardless of whether new molecular entity therapies were used. Participants will be monitored over 36 months, with possible extensions depending on study goals. Patients continue receiving treatment or no treatment based on routine clinical care determined by their physicians. This non-interventional study records medical decisions, treatments, and data without influencing patient care. Follow-up visits occur regularly, typically twice a year or more frequently during specific therapies, and retrospective data from prior visits may also be included. Participants will undergo evaluations including blood sample collection for HBV markers and immune response tests. Researchers will track HBsAg loss at 12 months as the primary outcome, along with other measures over time such as seroconversion rates, liver complications, and quality of life. The study involves ongoing documentation and monitoring aligned with clinical practice, with total participation lasting up to three years or longer.

CONDITIONS

Brief Title

HBsAg Declined Patients Follow-up Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have had an HBsAg decline of at least 0.5 log10 IU/mL in the past 12 months prior to screening due to any reason (with or without new molecular entities therapy).
  • Among enrolled subjects, 70% must have an HBsAg decline of at least 1 log10 IU/mL or actual values of at least 3 log10 IU/mL.
  • Able and willing to provide written informed consent and comply with the study protocol according to ICH and local regulations.
Not Eligible

You will not qualify if you...

  • Any condition that the investigator believes contraindicates participation in this study.
  • Currently participating in an interventional clinical study exploring HBV treatment.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 years (36 months after enrollment) with possible extension

Participants who had HBsAg decline in the past 6 months are monitored based on routine clinical practice. Medical decisions and procedures reflect standard care and are documented for study purposes.

Visits approximately every 6 months or more frequently depending on treatment (every 12 weeks during NUC therapy, every 2 to 4 weeks during interferon-α therapy)

Trial Site Locations

Total: 1 location

1

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

X

Xieer Liang, M.D.

Z

Zhihong Liu, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report.

Henry Lik-Yuen Chan, Alex Thompson, Michelle Martinot-Peignoux...

https://pubmed.ncbi.nlm.nih.gov/21718667