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

NCT ID: NCT05457920

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-09-30

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (continuous treatment group)

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.

Group Type: EXPERIMENTAL

continuous treatment

Intervention Type: BEHAVIORAL

The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFN α-2b 180μg once a week, or every 8 weeks of injection, 4 weeks off, periodically, the total treatment course does not exceed 96 weeks.

Group B (pulse therapy group)

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.

Group Type: EXPERIMENTAL

pulse therapy

Intervention Type: BEHAVIORAL

pulse therapy

Interventions

continuous treatment

The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFN α-2b 180μg once a week, or every 8 weeks of injection, 4 weeks off, periodically, the total treatment course does not exceed 96 weeks.

Intervention Type: BEHAVIORAL

pulse therapy

pulse therapy

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Shang

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Shang

Role: CONTACT

shangjia666@126.com

13938401888

Huibin Ning

Role: CONTACT

situhailuo@163.com

15981849054

Facility Contacts

Huibin Ning

Role: primary

situhailuo@163.com

15981849054

Other Identifiers

HenanPPHGRS

Identifier Type: -

Identifier Source: org_study_id