drugset / Trial / NCT05203055

Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia

NCT05203055

Phase 1/2 Unknown 300 enrolled Fuzhou General Hospital
RandomizedSingle-groupOpen-labelTreatment

Summary

To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.

Timeline

Start
2021-12-10
Primary completion
2022-12-10
Completion
2023-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 180 ug Subcutaneous
Background Etecavir Unknown 0.5 mg Oral
Background Tenofovir Small molecule 300 mg Oral