NCT05203055

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

A Multi-center, Open-label Study to Elucidate the Efficacy and Safety of Peginterferon Alpha-2b Therapy in the Initial Treatment of Chronic Hepatitis Patients With Normal ALT Level and Low Viremia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia

Interventions

Type	Name	Description
DRUG	Peginterferon alpha-2b	180μg/w
DRUG	Nucleotide Analog	Etecavir 0.5mg qd or Tenofovir 300mg qd
DRUG	pulse peginterferon alpha-2b	180μg/w for 8 consecutive weeks and cessation for 4 weeks

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-12-10
• Completion: 2023-12-10
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: China