Stopping antiviral treatment for chronic hepatitis B patients
Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
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 |
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Humanity & Health Medical Group Limited Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong SAR) |
| Trial ID | NCT03792919 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated potential success in treatment cessation for similar patient populations, suggesting this approach may be promising.
Eligibility criteria
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 this trial is running
Hong Kong, Hong Kong SAR
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.