orwegian Nucleoside Analogue Stop Study (Nuc-STOP) - A trial in chronic hepatitis B, aiming at achieving a functional cure

Phase 1

• Conditions: HBeAg negative chronic hepatitis B; MedDRA version: 20.1 Level: PT Classification code 10052297 Term: Hepatitis B e antigen negative System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-000724-34-SE
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

- Adults (18-70 years) with HBeAg negative chronic hepatitis B
- HBeAg negative at start of antiviral therapy
- Treated minimum 2 years with either tenofovir or entecavir without interruption
- Full viral suppression >2 years: at least 3 measurements at least 6 months apart with at least 24 months between the first and last measurement.
- Most recent liver fibrosis assessment, performed within the past 12 months, does not show advanced fibrosis (i.e. Metavir score
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- A history of decompensated liver disease, either by clinical signs (ascites, encephalopathy, portal hypertension, jaundice) or suggestive laboratory results (total bilirubin >38 umol/L, INR >1.5, platelets <75,000/mm3, serum albumin <30 g/L).
- Any previous diagnosis of cirrhosis, either by liver biopsy (Metavir score F4) or elastography (Fibroscan >12 kPa). Elastography readings with concomitant ALT >200 U/L are not considered.
- Previous HCC
- Co-infections with HIV, hepatitis C or hepatitis D
- Other disease or medication that can interfere with the study (e.g. ongoing alcohol or illicit drug abuse, immunosuppressive medication, other active liver disease, or any other condition which in the opinion of the physician is incompatible with participation)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified