drugset / Trial / NCT07183293
A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-10
- Primary completion
- 2027-03
- Completion
- 2031-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | — | Subcutaneous |
| Background | ETV | Unknown | — | — |
| Background | TAF | Unknown | — | — |
| Background | TDF | Unknown | — | — |
| Background | TMF | Unknown | — | — |