A study of peginterferon-alfa intervention to achieve hepatitis B surface antigen loss in chronic hepatitis B participants under long-term viral suppression with nucleoside analogues

Phase 2

• Conditions: Chronic Hepatitis B; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615000915550
• Lead Sponsor: Peter Angus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

*Informed consent
*Age > 18 years
*HBsAg-positive
*HBeAg negative
*On entecavir or tenofovir > 18 months
*HBV DNA level undetectable for > 18 months
*HBsAg < 1000 IU/mL

Exclusion Criteria

Severe liver disease which excludes them from peg-interferon

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HBsAg titre during antiviral therapy (pegIFNa plus NA therapy)<br>measured using the Roche Elecsys assay. This measures the quantitative<br>hepatitis B surface antigen (qHBsAg) titers expressed in international<br>units/mL (IU/mL).[48 weeks after commencement of treatment]