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

Nucleos(t)ide withdrawal in HBeAg negative hepatitis B virus infection to promote HBsAg clearance (NUC-B)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84346215

Enrollment

240

Registered

2016-11-11

Start date

2016-11-30

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Hepatology, Primary sub-specialty: Hepatology

Interventions

Patients will be electronically randomised using the InForm eCRF online custom built database to the two management arms in equal proportions using variable block sizes. Control Arm: Patients will d

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Efficacy is assessed at various timepoints after randomisation using various laboratory evaluations including immunology, virology and hepatology assessments. Specifically looking at the following: 1.1. The proportion of patients who achieve HBsAg loss who also have undetectable HBV DNA 1.2. The proportion of patients in each group who become inactive HBV carriers; i.e. achieve a sustained virological response (HBV DNA < 2000 IU/ml & normal ALT values) at 3 years 1.3. Magnitude of reduction in quantitative HBsAg levels at 1, 6, 12, 24 and 36 months 1.4. Magnitude of changes in antiviral T cells response at 1, 5, 6, 12, 24 and 36 months 1.5. Magnitude of changes in NK cells response at 1, 5, 6, 12, 24 and 36 months 2. Safety is assessed at various timepoints after randomisation using various laboratory evaluations. Specifically looking at the following: 2.1. The proportion of patients who achieve HBsAg loss who also have undetectable HBV DNA 2.2. The proportion of patients in each group who become inactive HBV carriers; i.e. achieve a sustained virological response (HBV DNA < 2000 IU/ml & normal ALT values) at 3 years 2.3. Magnitude of reduction in quantitative HBsAg levels at 1, 6, 12, 24 and 36 months 2.4. Magnitude of changes in antiviral T cells response at 1, 5, 6, 12, 24 and 36 months 2.5. Magnitude of changes in NK cells response at 1, 5, 6, 12, 24 and 36 months	—

Measure

Time frame

1. Efficacy is assessed at various timepoints after randomisation using various laboratory evaluations including immunology, virology and hepatology assessments. Specifically looking at the following: 1.1. The proportion of patients who achieve HBsAg loss who also have undetectable HBV DNA 1.2. The proportion of patients in each group who become inactive HBV carriers; i.e. achieve a sustained virological response (HBV DNA < 2000 IU/ml & normal ALT values) at 3 years 1.3. Magnitude of reduction in quantitative HBsAg levels at 1, 6, 12, 24 and 36 months 1.4. Magnitude of changes in antiviral T cells response at 1, 5, 6, 12, 24 and 36 months 1.5. Magnitude of changes in NK cells response at 1, 5, 6, 12, 24 and 36 months 2. Safety is assessed at various timepoints after randomisation using various laboratory evaluations. Specifically looking at the following: 2.1. The proportion of patients who achieve HBsAg loss who also have undetectable HBV DNA 2.2. The proportion of patients in each group who become inactive HBV carriers; i.e. achieve a sustained virological response (HBV DNA < 2000 IU/ml & normal ALT values) at 3 years 2.3. Magnitude of reduction in quantitative HBsAg levels at 1, 6, 12, 24 and 36 months 2.4. Magnitude of changes in antiviral T cells response at 1, 5, 6, 12, 24 and 36 months 2.5. Magnitude of changes in NK cells response at 1, 5, 6, 12, 24 and 36 months

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026