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NCT05203055

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

Status unknown Phase 1, PHASE2 Last updated 24 January 2022
What this trial tests

Phase 1, PHASE2 trial testing Peginterferon alpha-2b in Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia in 300 participants. Status unknown.

Timeline
10 December 2021
Primary endpoint
10 December 2022
10 December 2023

Quick facts

Lead sponsorFuzhou General Hospital
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment300
Start date10 December 2021
Primary completion10 December 2022
Estimated completion10 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fuzhou General Hospital

Who can join

Adults 18 to 60, any sex, with Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Peginterferon alpha-2b

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Other Fuzhou General Hospital trials

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