Long-Term Follow-up Study for Subjects with CHB Previously Treated with Imdusiran (AB-729)
Research type
Research Study
Full title
A Long-Term Follow-up Study for Subjects with Chronic Hepatitis B Previously Treated with Imdusiran (AB-729)
IRAS ID
1009829
Contact name
Lester Gibbs
Contact email
Sponsor organisation
Arbutus Biopharma Corporation
Clinicaltrials.gov Identifier
Research summary
Arbutus Biopharma is conducting clinical study AB-729-204 entitled “A Long-Term Follow-up Study for Subjects with Chronic Hepatitis B Previously Treated with Imdusiran (AB-729)”. This is a long-term follow-up study for subjects with chronic hepatitis B (CHB) who have participated in a prior study of imdusiran (AB-729) and met protocol-defined eligibility criteria to discontinue nucleos(t)ide analogue (NA) therapy, discontinued NA therapy, and remained off NA therapy at the End of Study visit. There is no investigational product used in this study. This study will only perform laboratory testing and concomitant medication reviews to monitor ongoing safety and hepatitis B virus (HBV) parameters in subjects who remain off NA therapy for an additional 2 years for evidence of ongoing HBV control, functional cure, or the need to restart NA therapy as defined by the protocol. Subjects who restart NA therapy will be assessed every 2 weeks until clinically stable. The expected enrollment for this study will be gradual as subjects complete their prior imdusiran study, and is expected to be about 35-40 subjects over the next 2-3 years.
REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0478
Date of REC Opinion
19 Sep 2024
REC opinion
Further Information Favourable Opinion