NCT06920329

Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

An Exploratory Clinical Study Evaluating the Impact of Interferon Consolidation Therapy on Intrahepatic cccDNA Levels in Chronic Hepatitis B Patients Who Achieved Clinical Cure With Peginterferon α-2b Therapy.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiamen Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Peginterferon α-2b based injection	Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.

Timeline

• Start date: 2025-04-20
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-04-09
• Last updated: 2025-04-09

Locations

1 site across 1 country: China