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Taking people in ItalyPhase 2

Tests ALG-000184 against tenofovir in adults with chronic hepatitis B

Tests ALG-000184 against tenofovir in untreated adults with chronic hepatitis B.

Key facts

Who runs it
Aligos Therapeutics Inc.
Where
Milan, Pisa, and Turin, ItalySee the 3 sitesAlso in 4 other countries, 15 sites
Registry title
Phase 2 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)
Status
Recruiting
Phase
Phase 2
People taking part
50 people, planned
Started
3 Dec 2025
Expected to end
31 Mar 2028
Type of study
Interventional
Record updated
12 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic hepatitis B who have not been treated recently, with HBeAg-positive disease in Part 1 and HBeAg-negative disease in Part 2.

Age
18 to 65 years, with a body mass index (BMI) of 18.0 to 35.0 kg/m2.
Sex
Men and women can join.
Disease stage
Chronic hepatitis B virus infection with HBV DNA of at least 20,000 IU/mL and HBsAg at or above the lower limit of quantification (LLOQ). ALT must be 8 times the upper limit of normal (ULN) or lower. No cirrhosis, no Metavir score F3 or higher, no liver decompensation.
Earlier treatment
People must never have had HBV antiviral treatment (NA, interferon) or an investigational anti-HBV drug. Or they must have been off such treatment for 6 months or 5 half-lives (whichever is longer) before randomization.
Biomarker or test result
HBeAg-positive and HBeAb-negative (Part 1), or HBeAg-negative (Part 2). HBsAg at or above LLOQ. HBV DNA of at least 20,000 IU/mL.

Main reasons for not taking part

  • Co-infection with hepatitis A, C, D, E or HIV, or other significant liver disease not caused by HBV
  • Positive for anti-HBs antibodies
  • Cirrhosis, Metavir score F3 or higher, or liver decompensation
  • Signs of liver cancer (hepatocellular carcinoma) on liver ultrasound
  • Investigational drug or device within 4 weeks (or 5 half-lives, whichever is longer) before the first dose

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2
  • 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 a serum ALT values of ≤8×ULN during screening
  • Must have the following chronic hepatitis B virus infection treatment status at screening: a. 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 b. 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)

Who cannot take part

  • Positive for anti-HBs antibodies
  • 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
  • Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology
  • Liver fibrosis that is classified as Metavir Score ≥F3 liver disease
  • History of, or current evidence of, hepatic decompensation
  • Exclusionary screening laboratory values include: a. Aspartate aminotransferase (AST) >8×ULN, b. Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected) c. International Normalization Ratio (INR) >1.2×ULN
  • History or current evidence of cirrhosis
  • Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound

Where in Italy

Also in 4 other countries, 15 sites

  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people

About the trial

What the trial wants to find out

To assess and compare monotherapy with ALG-000184 versus TDF in HBeAg-positive (Part 1) and HBeAg-negative (Part 2) subjects as measured by plasma HBV DNA levels.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 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 Virus Infection (B-SUPREME)
Plain-language title
Tests ALG-000184 against tenofovir in adults with chronic hepatitis BGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
12 June 2026