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

NCT05457920 | Unknown

• 1 other identifier: HenanPPHGRS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

inactive hepatitis B virus carriers; Pegylated Interferon α2b; Continuous treatment, pulse treatment

Outcome Measures

Primary Outcomes (1)

• Extent of HBsAg decrease at 48 weeks

  Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment

  48 weeks

Secondary Outcomes (2)

• HBsAg clearance at the end of 96 weeks of treatment

  96 weeks

• The decreasing extent of HBsAg level at 96 weeks

  96 weeks

Study Arms (2)

Group A (continuous treatment group)

EXPERIMENTAL

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.

Behavioral: continuous treatment

Group B (pulse therapy group)

EXPERIMENTAL

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.

Behavioral: pulse therapy

Interventions

continuous treatment 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 A (continuous treatment group)

pulse therapy BEHAVIORAL

pulse therapy

Group B (pulse therapy group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jia Shang

  Henan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Jia Shang

CONTACT

13938401888; shangjia666@126.com

Huibin Ning

CONTACT

15981849054; situhailuo@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: October 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: September 30, 2024
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: End of study
• Access Criteria: Editors and reviewers of contributing magazines

Locations

CN (1)