HBsAg Declined Patients Follow-up Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNanfang Hospital, Southern Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
at week 48Secondary outcomes
1
Proportion of participants with HBsAg loss or HBsAg seroconversion.
HBsAg loss / seroconversion at each study visit
Time frame
at week 48, 96 and 1442
Change from baseline in quantitative HBsAg levels over time
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
Time frame
at week 48, 96 and 1443
Change from baseline in quantitative anti-HBs levels over time
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)
Time frame
at week 48, 96 and 1444
Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit
The incidence of de novo liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality
Time frame
at week 48, 96 and 144Sponsors and contacts
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Source ClinicalTrials.gov