In short
Clinical trials are investigating ALG-000184 in adults with chronic hepatitis B. The main study compares ALG-000184 with tenofovir disoproxil fumarate to see how well they lower hepatitis B virus levels and how safe they are. The trial includes both HBeAg-positive and HBeAg-negative untreated adults.
Key points
- ALG-000184 is being studied in a Phase 2 trial for adults with chronic hepatitis B. The study includes untreated people who are HBeAg-positive and HBeAg-negative. Researchers are comparing ALG-000184 with tenofovir disoproxil fumarate. The main goal is to see whether plasma HBV DNA drops below the study limit at Week 48. The trial is authorised and plans to enroll 195 participants.
Trial overview
The available study of ALG-000184 is a Phase 2 interventional trial in adults with chronic hepatitis B virus infection. The trial is titled B-SUPREME and is designed to evaluate both efficacy and safety by comparing ALG-000184 with tenofovir disoproxil fumarate.
This study is focused on people who have not yet been treated and includes both HBeAg-positive and HBeAg-negative adults. The goal is to see how well treatment lowers HBV DNA, which is the amount of hepatitis B virus in the blood.
Who can participate
The trial is for untreated adult subjects with chronic hepatitis B. It includes two groups: people who are HBeAg-positive and people who are HBeAg-negative.
HBeAg is a hepatitis B marker used to describe how active the infection is. The study is split into Part 1 for HBeAg-positive participants and Part 2 for HBeAg-negative participants.
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. 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).
LLOQ means the lower limit of quantification, which is the lowest level a test can measure reliably. TD means target detected, and TND means target not detected; both are ways of describing whether virus is still found in the sample.
Study design and comparators
This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes. The study compares ALG-000184 with tenofovir disoproxil fumarate, using placebo forms of the study drug and the comparator to support the comparison.
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. Monotherapy means treatment with one main medicine at a time.
Trial status and size
The study status is Authorised, which means it has official approval to run. The planned enrollment is 195 participants, so the study aims to include 195 people in total.
At this stage, the trial data show one main study for ALG-000184 in chronic hepatitis B. 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.