Chronic hepatitis B Hepatitis B
Conditions
Interventions
In Arm A, patients will receive a placebo that mimics the appearance and administration schedule of NAs.,In Arm B, patients will continue NAs therapy according to current APASL guidelines.
Stopping nucleos(t)ide analogue (NAs) therapy,Contnuing nucleos(t)ide analogue (NAs) therapy
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with chronic hepatitis B (CHB), identified through ICD codes B18.0, B18.1, B18.8, B18.9, or a positive HBsAg test for over six months, will be evaluated based on the following inclusion criteria: 1. Patients must be aged 18 years or older at the time of enrollment. 2. Patients must have been continuously HBeAg-negative from the start of NAs treatment until inclusion in the study. 3. Patients must have a quantitative HBsAg (qHBsAg) level of equal or below 100 IU/mL, tested using the Roche Elecsys HBsAg II Quant reagent kit, which has a lower limit of detection of 0.05 IU/mL. 4. Patients must have received continuous treatment with approved NAs for not less than two years, demonstrating undetectable HBV DNA on three separate occasions, each at least 6 months apart. 5. Patients must have normal alanine aminotransferase (ALT) levels at the time of inclusion.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Patients who were initially HBeAg-positive at the start of NAs treatment. 2. Patients with a history of decompensation, indicated by a serum total bilirubin level of more than or equal 2 mg/dL, increased international normalized ratio, clinical jaundice, ascites, variceal bleeding, or hepatic encephalopathy. 3. Patients with signs of liver cirrhosis based on histologic findings, or ultrasonographic, CT, or MRI evidence, with or without splenomegaly (within one year before screening), and/or liver stiffness measurement of more than or equal 11.0 kPa by elastography (FibroScan) at screening. 4. Patients with evidence of hepatocellular carcinoma (HCC), concomitant human immunodeficiency or hepatitis C virus infections. 5. Pregnant patients. 6. Patients who received pegylated interferon treatment prior to NAs cessation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg loss rate 48 weeks percentage,HBsAg loss rate 96 weeks percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Relapse Rate 96 weeks percentage,Virological Replase Rate 96 weeks percentage | — |
Countries
Thailand
Contacts
Public ContactSoe Thiha Maung
Division of Gastroenterology, Department of Medicine, King Chulalongkorn Memorial Hospital
Outcome results
None listed