Table of contents
- Trial overview
- Who can participate
- What the study measures
- Study design and comparators
- Trial status and size
Trial overview
The available study of ALG-000184 is a Phase 2 interventional trial in adults with chronic hepatitis B virus infection.[1] The trial is titled B-SUPREME and is designed to evaluate both efficacy and safety by comparing ALG-000184 with tenofovir disoproxil fumarate.[1]
This study is focused on people who have not yet been treated and includes both HBeAg-positive and HBeAg-negative adults.[1] The goal is to see how well treatment lowers HBV DNA, which is the amount of hepatitis B virus in the blood.[1]
Who can participate
The trial is for untreated adult subjects with chronic hepatitis B.[1] It includes two groups: people who are HBeAg-positive and people who are HBeAg-negative.[1]
HBeAg is a hepatitis B marker used to describe how active the infection is.[1] The study is split into Part 1 for HBeAg-positive participants and Part 2 for HBeAg-negative participants.[1]
What the study measures
The main endpoint, or main result the researchers measure, is whether plasma HBV DNA is below the study limit at Week 48.[1] For Part 1, the target is plasma HBV DNA < LLOQ (10 IU/mL, TD or TND), and for Part 2, the target is plasma HBV DNA < LLOQ (10 IU/mL, TND).[1]
LLOQ means the lower limit of quantification, which is the lowest level a test can measure reliably.[1] TD means target detected, and TND means target not detected; both are ways of describing whether virus is still found in the sample.[1]
Study design and comparators
This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes.[1] The study compares ALG-000184 with tenofovir disoproxil fumarate, using placebo forms of the study drug and the comparator to support the comparison.[1]
The brief study summary says the purpose is to assess and compare monotherapy with ALG-000184 versus TDF in both HBeAg-positive and HBeAg-negative subjects, based on plasma HBV DNA levels.[1] Monotherapy means treatment with one main medicine at a time.[1]
Trial status and size
The study status is Authorised, which means it has official approval to run.[1] The planned enrollment is 195 participants, so the study aims to include 195 people in total.[1]
At this stage, the trial data show one main study for ALG-000184 in chronic hepatitis B.[1] The key focus is whether the treatment can reduce virus levels in the blood by Week 48 in both HBeAg-positive and HBeAg-negative adults.[1]
