Clinical trial NCT06920329: Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Hepatitis b
Keywords: Peginterferon α-2b injection
cccDNA
pgRNA
Lead sponsor: Xiamen Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
timeFrame: baseline to week48
measure: Clearance rate of intrahepatic cccDNA
timeFrame: week48
Secondary outcomes:
measure: Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
timeFrame: baseline to week48
measure: Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
timeFrame: baseline to week48
measure: Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
timeFrame: week48
measure: Changes in intrahepatic cccDNA levels
timeFrame: baseline to week48
measure: Changes in intrahepatic HBsAg levels
timeFrame: baseline to week48
measure: intrahepatic HBsAg clearance rate
timeFrame: baseline、week48
measure: Histopathological scores in hepatic inflammation and fibrosis
timeFrame: baseline、week48
measure: Recurrence rate
timeFrame: baseline to week48
measure: Adverse Event#AE#
timeFrame: baseline to week48
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
state: Fujian
Study officials:
affiliation: Xiamen Hospital of Traditional Chinese Medicine
name: Huiqing Liang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: