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

Not Applicable

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Behavioral: pulse therapy; Behavioral: continuous treatment

• Registration Number: NCT05457920
• Lead Sponsor: Henan Provincial People's Hospital

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2023-10-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (pulse therapy group)	pulse therapy	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 A (continuous treatment group)	continuous treatment	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.

Primary Outcome Measures

Name	Time	Method
Extent of HBsAg decrease at 48 weeks	48 weeks	Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment

Secondary Outcome Measures

Name	Time	Method
The decreasing extent of HBsAg level at 96 weeks	96 weeks	Decreasing level and difference of HBsAg in different treatment groups after 96 week treatment
HBsAg clearance at the end of 96 weeks of treatment	96 weeks	To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 96 week treatment

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China