A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
NCT07183293 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-19
Summary
This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
Conditions
- HBV-related Liver Cirrhosis
Interventions
- DRUG
-
Peginterferon alfa-2b combined with NAs
Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.
- DRUG
-
NAs
Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.
Sponsors & Collaborators
-
Xiamen Humanity Hospital
lead OTHER
Principal Investigators
-
Wenqi Huang · Xiamen Humanity Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2027-03-31
- Completion
- 2031-09-30
Countries
- China
Study Locations
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