A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumar… (NCT06963710) | Clinical Trial Compass
RecruitingPhase 2
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)
United States200 participantsStarted 2025-07-15
Plain-language summary
This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
✓. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
✓. HBsAg ≥LLOQ.
✓. HBV DNA ≥20,000 IU/mL.
✓. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
✓. Must have the following chronic hepatitis B virus infection treatment status at screening:
✓. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR
✓. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).
Exclusion criteria
✕. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
✕. Positive for anti-HBs antibodies.
✕. History or current evidence of cirrhosis.
✕
What they're measuring
1
HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)
Timeframe: 48 weeks
2
HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)
. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
✕. History of, or current evidence of, hepatic decompensation.
✕. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
✕. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug