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

Chronic Hepatitis B Clinical Trial

Official title:

The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457920
• Other study ID #: HenanPPHGRS
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2022
• Source: Henan Provincial People's Hospital
• Contact: Jia Shang
• Phone: 13938401888
• Email: shangjia666[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of HBsAg decrease at 48 weeks	Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment	48 weeks
Secondary	HBsAg clearance at the end of 96 weeks of treatment	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	96 weeks
Secondary	The decreasing extent of HBsAg level at 96 weeks	Decreasing level and difference of HBsAg in different treatment groups after 96 week treatment	96 weeks