Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06963710 | 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) | PHASE2 | RECRUITING | 200 | — | — | Jul 15, 2025 | Aug 1, 2028 | May 1, 2026 | 58 | United States, Bulgaria +12 |
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48
| Arm | Type | Description |
|---|---|---|
| ALG-000184 | EXPERIMENTAL | Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks. |
| TDF | ACTIVE_COMPARATOR | Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks. |
| Name | Type | Description |
|---|---|---|
| ALG-000184 | DRUG | 300 mg tablet |
| TDF | DRUG | 300 mg tablet |
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...