HBsAg Declined Patients Follow-up Study

NCT05977283 | Recruiting

• 1 other identifier: NFEC-2022-260
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are: \- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy). Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.

Conditions

Hepatitis B; Hepatitis B, Chronic

Keywords

chronic hepatitis b; HBsAg; functional cure

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months

  Describe treatment pattern and its impact on HBsAg loss of the included patients (with or without new molecular entities therapy) by the proportion of participants with HBsAg loss at week 48.

  at week 48

Secondary Outcomes (5)

• Proportion of participants with HBsAg loss or HBsAg seroconversion.

  at week 48, 96 and 144

• Change from baseline in quantitative HBsAg levels over time

  at week 48, 96 and 144

• Change from baseline in quantitative anti-HBs levels over time

  at week 48, 96 and 144

• Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit

  at week 48, 96 and 144

• The change of Health-related quality-of-life (HRQoL) over time

  at week 48, 96 and 144

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.

You may qualify if:

• Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
• Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonization (ICH) and local regulations.

You may not qualify if:

• Any condition which, in the opinion of the investigator, contraindicates their participant in this study.
• Participants who are currently participating in interventional clinical study exploring HBV treatment.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (5)

• BLUMBERG BS, ALTER HJ, VISNICH S. A "NEW" ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.

  PMID: 14239025 BACKGROUND

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

  PMID: 28427875 BACKGROUND

• Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available.

  PMID: 20185190 BACKGROUND

• Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.

  PMID: 21718667 BACKGROUND

• - Lau G K K, Marcellin P, Brunetto M, et al. 917 on-treatment monitoring of HBsAg levels to predict response to peginterferon alfa-2a in patients with HBeAg-positive chronic hepatitis B[J]. Journal of Hepatology, 2009, 50, Supplement 1(0): S333

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to store a certain amount of blood samples in site during study visit for future HBV markers, host immunity or other related tests. The retained remaining samples from previous tests before this follow-up study may also be used for HBV related exploratory research after patient informed consent.

MeSH Terms

Conditions

Hepatitis B; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jinlin hou, Master

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xieer Liang, M.D.

CONTACT

+862062787432; freeliang@163.com

Zhihong Liu, M.D.

CONTACT

+862062787432; liucas@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: August 4, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)