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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: Peginterferon α-2b based injection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiqing Liang, Ph.D; Phone Number: 13306051108; Email: 13306051108@163.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • Xiamen Hospital of Traditional Chinese Medicine
      • Contact: Huiqing, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
• Aged 18-65 years (inclusive), no gender restriction;
• A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
• First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
• Agreement to undergo two liver biopsies during the study;
• Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.

Exclusion Criteria:

• Lactating women;
• Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
• Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
• Evidence of hepatocellular carcinoma;
• Prothrombin time (PT) or INR > ULN;
• Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon α-2b based group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels	baseline to week48
Clearance rate of intrahepatic cccDNA	week48

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy	baseline to week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy	baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy	week48
Changes in intrahepatic cccDNA levels	baseline to week48
Changes in intrahepatic HBsAg levels	baseline to week48
intrahepatic HBsAg clearance rate	baseline、week48
Histopathological scores in hepatic inflammation and fibrosis	baseline、week48
Recurrence rate	baseline to week48
Adverse Event#AE#	baseline to week48

Collaborators and Investigators

• Sponsor: Xiamen Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Huiqing Liang, Ph.D, Xiamen Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cccDNA; Peginterferon α-2b injection; pgRNA
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: 2024K04701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No