Clinical trial NCT05457920: Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)
Official title: The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: inactive hepatitis B virus carriers
Pegylated Interferon α2b
Continuous treatment, pulse treatment
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.

Detailed description: Patients:chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml). The study patients were divided into two groups.Group A (PEG IFN α- 2b continuous group): PEG IFN was injected subcutaneously once a week from the first day of baseline α- 2b 180 μg. The total course of treatment should not exceed 96 weeks.Group B (PEG IFN α- 2b pulse group): from the first day of baseline, PEG IFN was injected subcutaneously α- 2b 180 μg. Every 8 weeks of injection, stop for 4 weeks, and conduct it periodically.Two groups at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72weeks, 84 weeks, 96 weeks and the 12th and 24th weeks after drug withdrawal, and corresponding examinations were carried out at each follow-up.Check and record adverse events and concomitant medication in detail, and evaluate the compliance of subjects; Blood samples were retained and transported to the laboratory for HBV at baseline, 24 weeks, 48weeks, 72, 96, and 12 and 24 after drug withdrawal.DNA quantification and detection of hepatitis B virus markers.The efficacy and safety were evaluated after the study.

Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years, both male and female (including 18 and 65 years old);
* HBV DNA≤2000 IU/ml and HBeAg negative;
* HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml;
* ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks);
* A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose;
* B-ultrasound or fibroscan suggest no liver cirrhosis;
* Willing to accept treatment and sign informed consent.

Exclusion Criteria:

* Participants with other hepatotropic viruses or human immunodeficiency virus co-infection;
* other chronic non-viral liver diseases or decompensated liver diseases;
* tumours;
* drug abuse;
* severe psychiatric disease;
* uncontrolled thyroid disease or diabetes;
* pregnancy or lactation.

Primary outcomes:
measure: Extent of HBsAg decrease at 48 weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: HBsAg clearance at the end of 96 weeks of treatment
timeFrame: 96 weeks
measure: The decreasing extent of HBsAg level at 96 weeks
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Jia Shang
role: STUDY_CHAIR
References: