Status:
NOT_YET_RECRUITING
Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.
Lead Sponsor:
Xiamen Hospital of Traditional Chinese Medicine
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
NA
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. Eli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06920329
Start Date
April 20 2025
End Date
March 31 2028
Last Update
April 9 2025
Active Locations (1)
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1
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China