NCT03792919

Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)

Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Humanity & Health Medical Group Limited · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.

Detailed description

Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Stop current treatment (anti-HBV neucleos(t)ides)	Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
DRUG	Keep current treatment (anti-HBV neucleos(t)ides)	Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.

Timeline

• Start date: 2018-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-01-04
• Last updated: 2025-03-24

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study