Clinical Trials in Italy / NCT06963710
Active, not recruiting
Phase 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)
NCT06963710 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Chronic Hepatitis B Infection
Investigational drug(s) / intervention(s)
ALG-000184 →TDF
ALG-000184: 300 mg tablet
TDF: 300 mg tablet
Study 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.
Eligibility
Key Inclusion Criteria:
1. 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).
2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
3. HBsAg ≥LLOQ.
4. HBV DNA ≥20,000 IU/mL.
5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
6. Must have the following chronic hepatitis B virus infection treatment status at screening:
1. 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
2. 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).
Key Exclusion Criteria:
1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
2. Positive for anti-HBs antibodies.
3. History or current evidence of cirrhosis.
4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
5. History of, or current evidence of, hepatic decompensation.
6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
7. 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
8. Exclusionary screening laboratory values include:
1. Aspartate aminotransferase (AST) \>8×ULN,
2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
3. International Normalization Ratio (INR) \>1.2×ULN
Primary outcome measure(s)
- 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
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| Aligos Investigational Site | Coronado | California | |
| Aligos Investigational Site | Pasadena | California | |
| Aligos Investigational Site | Rialto | California | |
| Aligos Investigational Site | San Francisco | California | |
| Aligos Investigational Site | San Jose | California | |
| Aligos Investigational Site | Miami | Florida | |
| Aligos Investigational Sites | Sofia | Bulgaria | |
| Aligos Investigational Site | Edmonton | Canada | |
| Aligos Investigational Site | Ottawa | Canada | |
| Aligos Investigational Site | Toronto | Canada | |
| Aligos Investigational Sites | Vancouver | Canada | |
| Aligos Investigational Sites | Beijing | China | |
| Aligos Investigational Site | Changchun | China | |
| Aligos Investigational Site | Chengdu | China | |
| Aligos Investigational Site | Chongqing | China | |
| Aligos Investigational Sites | Guangzhou | China | |
| Aligos Investigational Site | Nanjing | China | |
| Aligos Investigational Sites | Shanghai | China | |
| Aligos Investigational Site | Clichy | France | |
| Aligos Investigational Site | Limoges | France | |
| Aligos Investigational Site | Nice | France | |
| Aligos Investigational Site | Toulouse | France | |
| Aligos Investigational Sites | Hong Kong | Hong Kong | |
| Aligos Investigational Site | Milan | Italy | |
| Aligos Investigational Site | Chisinau | Moldova | |
| Aligos Investigational Site | Auckland | New Zealand | |
| Aligos Investigational Sites | Bucharest | Romania | |
| Aligos Investigational Site | Ansan | South Korea | |
| Aligos Investigational Site | Busan | South Korea | |
| Aligos Investigational Sites | Seoul | South Korea | |
| Aligos Investigational Site | Ulsan | South Korea | |
| Aligos Investigational Site | Yangsan | South Korea | |
| Aligos Investigational Site | Pontevedra | Spain | |
| Aligos Investigational Site | Chiayi City | Taiwan | |
| Aligos Investigational Site | Kaohsiung City | Taiwan | |
| Aligos Investigational Site | Taichung | Taiwan | |
| Aligos Investigational Site | Tainan | Taiwan | |
| Aligos Investigational Site | Taipei | Taiwan | |
| Aligos Investigational Site | Glasgow | United Kingdom | |
| Aligos Investigational Site | Leicester | United Kingdom |
+ 1 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06963710 on ClinicalTrials.gov ↗ ← All trials in Italy