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

NCT ID: NCT06920329

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2028-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon α-2b based group

Group Type: EXPERIMENTAL

Peginterferon α-2b based injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Liang Huiqing

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huiqing Liang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Xiamen Hospital of Traditional Chinese Medicine

Locations

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China

Countries

China

Central Contacts

Huiqing Liang, Ph.D

Role: CONTACT

13306051108@163.com

13306051108

Facility Contacts

Huiqing, Ph.D

Role: primary

Other Identifiers

2024K04701

Identifier Type: -

Identifier Source: org_study_id