Can we stop antiviral medicines safely and effectively in patients with chronic hepatitis B and help to increase the chance of cure?

Not Applicable

• Conditions: Hepatitis B; Infection - Other infectious diseases

• Registration Number: ACTRN12619001441101
• Lead Sponsor: Dr Tien Huey Lim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-17
• Last Update Posted: 22 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Non-cirrhotic patients with chronic hepatitis B (CHB), on nucleos(t)ide analogue (NA) therapy for at least 2 years
- Age 18-60 years
- Normal ALT level at screening
- HBV DNA undetectable levels x3 (>6 months apart)
- HBsAg levels <100 IU/mL within the last 3 months

Exclusion Criteria

- Patients with cirrhosis/severe fibrosis (Fibroscan >9kpa), hepatocellular carcinoma
- Other significant medical co-morbidities
- Patients who have history of significant non compliance
- Significant alcohol consumption (>30g/day for women and >50g/day for men)
- Poor venous access

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Rates of HBsAg loss (this is a blood test and patients would either have lost HBsAg or not lost HBsAg<br><br>[Outcome 1: rates of HBsAg loss at end of year 1 and year 5<br>];2)Rates of sustained virological response off treatment (defined by serum HBV DNA <2000IU/mL plus serum ALT (alanine aminotransferase) level <ULN (upper limit of normal) between week 24 and week 52 (end of first study year) and up to 5 years<br>[week 24, week 52 and year 5]