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A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) \< lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
Princess Margaret Hospital (Hong Kong)
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Start Date
August 14, 2021
Primary Completion Date
January 23, 2024
Completion Date
July 19, 2024
Last Updated
July 24, 2025
103
ACTUAL participants
Tenofovir Alafenamide
DRUG
VIR-2218
DRUG
Nivolumab
DRUG
Selgantolimod
DRUG
Lead Sponsor
Gilead Sciences
Collaborators
NCT06671093
NCT06885710
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06263959