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

Launched by HUMANITY & HEALTH MEDICAL GROUP LIMITED · Jan 3, 2019

Keywords

ClinConnect Summary

The CNAVK clinical trial is looking at whether some patients with chronic hepatitis B (CHB) can safely stop their long-term antiviral medications, called nucleos(t)ide analogues (NAs), without risking their health. Researchers want to find out if patients who have been stable on these medications can maintain a healthy viral status and possibly clear the virus from their system after stopping the treatment. The trial is currently recruiting participants of all ages and genders.

To be eligible for this study, participants must have a positive hepatitis B surface antigen (HBsAg) result, be negative for another marker (HBeAg), and have been on antiviral therapy for over a year and a half. Additionally, they need to have shown that their virus levels were undetectable on three separate tests, spaced at least six months apart. If you join this trial, you can expect to work closely with healthcare professionals who will monitor your progress and health closely during the study. It's important to note that patients with other liver diseases or those who are hesitant to stop their treatment will not be able to participate.

Gender

ALL

Eligibility 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.