Treatment withdrawal in patients with hepatitis B virus infection to promote clearance of the virus from the body

Phase 1

• Conditions: Hepatitis B viral infection; MedDRA version: 19.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10052297Term: Hepatitis B e antigen negativeSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001010-17-GB
• Lead Sponsor: Imperial College, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-13
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

•Age = 18
•Chronic HBV infection
•HBeAg negative
•Nucleos(t)ide analogues treatment for =3 years
•HBV DNA < 400 IU/ml =2 years
•Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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

Study & Design

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