Phase 2 Study of ALG-000184 for Chronic Hepatitis B
This study is testing a new medication called ALG-000184 against a standard treatment, tenofovir disoproxil fumarate (TDF), for adults with chronic hepatitis B infection. Researchers want to see how well ALG-000184 works and if it's safe over 48 weeks. You might be eligible if you are 18 to 65 years old, have chronic hepatitis B (HBeAg-positive or HBeAg-negative), and meet certain blood test requirements for the virus. The main goal is to see if the amount of hepatitis B virus (HBV DNA) in your blood drops to a very low level after 48 weeks of treatment. About 200 people are expected to join this study, but its current status is unclear.
- Study design
- This is a randomized, double-blind, active-controlled Phase 2 study involving about 200 participants, comparing ALG-000184 to tenofovir disoproxil fumarate (TDF). Participants will be assigned to receive one of the treatments without knowing which one it is.
- What's involved
- Participants will take an oral medication once daily for 48 weeks. After this period, all participants will receive ALG-000184 for an additional 48 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 48 weeks during the initial treatment period, and then for an additional 48 weeks during an open-label extension period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
At a glance
Conditions
Where it's being run
58 sites across 21 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)48 weeks
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
- HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)48 weeks
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48