HBsAg Declined Patients Follow-up Study

Recruiting

• Conditions: Hepatitis B; Hepatitis B, Chronic

• Registration Number: NCT05977283
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

This study is a retrospective and prospective follow-up study for participants who had HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy). The follow-up period will be 3 years (36 months after enrollment) and may be extended upon expiration according to study objectives. Patients are treated or untreated based on current clinical practice guidelines, and every medical decision and course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation. The conduct of this non-interventional follow-up study and its documentation procedures will not affect the routine treatment of the subjects. It is only requested that any medical decisions, procedures and data during this study be documented in the electronic case report/record form (eCRF) according to the study protocol as available from routine medical care. Diagnostic testing and monitoring procedures are exclusively based on the decision of the treating physician.

In general, patients with hepatitis B should be monitored at least twice a year (every 6 months), every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy in accordance with clinical needs (Table 3-1 and Table 3-2). For patients had HBsAg decline in past 6 months due to new molecular entities therapy, The baseline of this follow-up study is the time when NME discontinued (within 28 days of the last does of NME or within 2 half-life period of the NME). For patients had HBsAg decline in past 6 months without new molecular entities therapy, the baseline should be the time of enrolling in the study. The time of enrolling in this study may be posterior or equal to baseline, which is not necessarily the baseline of this study. The visit window period is ±28 days for patients with NUC therapy and ±7 days for patients with interferon-α therapy. Follow-up study visit data can be collected retrospectively if it has been performed before entry of this study.

Medical decisions, procedures and data before this follow-up study will also be documented if available. 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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study Start: 2023-05-11
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20
• Primary Completion: 2027-06
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months	at week 48	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.

Secondary Outcome Measures

Name	Time	Method
The change of Health-related quality-of-life (HRQoL) over time	at week 48, 96 and 144	evaluated the risk factors on the progression of CHB, by the available data
Proportion of participants with HBsAg loss or HBsAg seroconversion.	at week 48, 96 and 144	HBsAg loss / seroconversion at each study visit
Change from baseline in quantitative anti-HBs levels over time	at week 48, 96 and 144	Describe the development of anti-HBs over time for hepatitis B patients with HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy)
Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit	at week 48, 96 and 144	The incidence of de novo liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality
Change from baseline in quantitative HBsAg levels over time	at week 48, 96 and 144	including but not limited to actual values and changes from Baseline (Pre-treatment, 6 month prior to screening, and the beginning of follow-up study) at week 48, 96 and 144 in HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA level

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China