Stopping antiviral treatment for chronic hepatitis B patients
Official title: Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
Run by Humanity & Health Medical Group Limited · NCT03792919 · Data updated 2026-11-12
This study is testing if people with chronic hepatitis B can safely stop their antiviral medication after being stable for over a year and still maintain good health outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Humanity & Health Medical Group Limited Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong SAR) |
| Status | Recruiting |
| Started | December 1, 2018 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | March 24, 2025 |
| Trial ID | NCT03792919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HBsAg positive, HBeAg negative CHB patients who have been on stable NAs therapy for at least 18 months and have undetectable HBV DNA.
✕Probably not a fit
Patients with other liver diseases, concurrent hepatitis viruses, or those unwilling to stop their anti-HBV treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify chronic hepatitis B (CHB) patients who can safely discontinue nucleos(t)ide analogues (NAs) while maintaining satisfactory clinical outcomes, such as sustained viral remission and HBsAg clearance. It involves comparing the effects of stopping NAs versus continuing treatment in patients who have been stable on NAs for over a year and a half. The study will assess the potential benefits of treatment cessation based on previous findings that suggest increased HBsAg clearance rates after stopping NAs.
Why it matters
Potential benefit: If successful, this study could provide a pathway for CHB patients to safely discontinue antiviral treatment while achieving better health outcomes.
How similar studies have gone: Previous studies have indicated potential success in treatment cessation for similar patient populations, suggesting this approach may be promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive; 2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year; 3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule; 4. Patients read, understand the consent form, and signed the study consent. Exclusion Criteria: 1. Patient with other liver diseases; 2. Patient with concurrent hepatitis viruses or HIV infection; 3. Patients are reluctant to stop their anti-HBV treatment.
Where it's running
-
Humanity & Health Research Centre
Hong Kong, Hong Kong SAR, Hong Kong Recruiting
Study contacts
- Study coordinator: George Lau, MD
- Email: gkklau@netvigator.com
- Phone: 852-28613777
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Impact of functional cure on patient-reported outcomes in chronic hepatitis B
This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.
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This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.
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Combination therapy for functional cure in chronic hepatitis B
This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.
-
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This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.
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AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.