Humanity & Health Research Centre
Hong Kong, Hong Kong SAR
Location status: Recruiting
NCT Number: NCT03792919
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.
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Interventional
Phase 4
Hong Kong, Hong Kong SAR
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of HBsAg clearance during the off-treatment period
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of HBsAg seroconversion during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of sustain HBV viral submission during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of sustain biological response during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of hepatocellular carcinoma during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of Liver failure during the off-treatment period
Contact information is provided by the study sponsor or research team.
Danny Wang
CONTACT
George Lau, MD
CONTACT
Humanity & Health Medical Group Limited
Other
Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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