Chronic Hepatitis b
Conditions
Keywords
Peginterferon α-2b injection, cccDNA, pgRNA
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.
Interventions
DRUGPeginterferon 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.
Sponsors
Xiamen Hospital of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in intrahepatic cccDNA and peripheral blood pgRNA levels | baseline to week48 |
| Clearance rate of intrahepatic cccDNA | week48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy | baseline to week48 |
| Histopathological scores in hepatic inflammation and fibrosis | baseline、week48 |
| Recurrence rate | baseline to week48 |
| Adverse Event#AE# | baseline to week48 |
| intrahepatic HBsAg clearance rate | baseline、week48 |
| Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy | baseline to week48 |
Countries
China
Contacts
Primary ContactHuiqing Liang, Ph.D
Outcome results
None listed