Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)

Zhengzhou University

Status: Enrolling

Conditions: Chronic Hepatitis B

Treatments: Behavioral: pulse therapy; Behavioral: continuous treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05457920

HenanPPHGRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group A (continuous treatment group)

Experimental group

Description:

The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180μg once a week, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment.

Treatment:

Behavioral: continuous treatment

Group B (pulse therapy group)

Experimental group

Description:

The treatment period is 12 weeks as a treatment unit. From the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180 μg, every injection for 8 weeks, stop for 4 weeks, periodically, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment.

Treatment:

Behavioral: pulse therapy