The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Extent of HBsAg decrease at 48 weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •drug abuse;
- •severe psychiatric disease;
- •uncontrolled thyroid disease or diabetes;
- •pregnancy or lactation.
Arms & Interventions
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.
Intervention: continuous treatment (Behavioral)
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.
Intervention: pulse therapy (Behavioral)
Outcomes
Primary Outcomes
Extent of HBsAg decrease at 48 weeks
Time Frame: 48 weeks
Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment
Secondary Outcomes
- The decreasing extent of HBsAg level at 96 weeks(96 weeks)
- HBsAg clearance at the end of 96 weeks of treatment(96 weeks)