ucleos(t)ide withdrawal in Hepatitis B virus infection (NUC-B)

Phase 2

• Conditions: Specialty: Hepatology, Primary sub-specialty: Hepatology; UKCRC code/ Disease: Infection/ Viral hepatitis; Infections and Infestations; Hepatitis B

• Registration Number: ISRCTN84346215
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-11
• Last Update Posted: 4 October 2021
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Aged 18 years and over
2. Chronic HBV infection
3. HBeAg negative
4. Nucleos(t)ide analogues treatment for =3 years
5. HBV DNA < 400 IU/ml =2 years
6. Informed consent

Exclusion Criteria

1. Cirrhosis at any time
2. HBeAg to anti-HBe seroconversion within the last 3 years
3. Interferon use in the last 3 years
4. Contraindications to interferon use
5. Participation in HBV-specific therapeutic vaccine studies within 12 months
6. HCV, HDV or HIV co-infection
7. Immunosuppressant use
8. Clinically significant comorbidities that, in the opinion of the investigator, render the patient unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HBsAg (Hepatitis B surface antigen) is measured using standard laboratory ELISA assays at baseline and 3 years.