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The Clinical Cure Project of Chronic Hepatitis B in China

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 30, 2023 to Dec 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2024 to Jun 30, 2026
    • Site details revised
    v5
  2. Study arms: 2 to 3v4
  3. Primary completion date: Dec 30, 2021 to Jun 30, 2023
    • Study completion date: Dec 31, 2023 to Jun 30, 2024
    v3
  4. Study completion date: Dec 30, 2022 to Dec 31, 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA\<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.
Trial Details
NCT Number NCT04035837
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Conditions
(from sponsor)		 Hepatitis B, Chronic
Related terms Hepatitis B, Chronic
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov