Stopping Nucleos(t)ide Analogues in HBeAg-negative and Non-cirrhotic Chronic Hepatitis B Patients: A Double-blinded Randomized-controlled Trial

Phase 4

• Conditions: Chronic hepatitis B; Hepatitis B

• Registration Number: TCTR20240818004
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-18
• Last Update Posted: 19 August 2024
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 74

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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified