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

Xiamen Hospital of Traditional Chinese Medicine

Status

Not yet enrolling

Conditions

Chronic Hepatitis b

Treatments

Drug: Peginterferon α-2b based injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06920329

2024K04701

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.