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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00907894 | Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B | PHASE1 | COMPLETED | 22 | — | — | Feb 1, 2009 | - | Dec 19, 2020 | 7 | Belgium, Germany +2 |
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
| Arm | Type | Description |
|---|---|---|
| Stratum 1 | EXPERIMENTAL | - |
| Stratum 2 | EXPERIMENTAL | - |
| Stratum 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LDT600 (Telbivudine) | DRUG | LDT600 (Telbivudine) |
Inclusion Criteria: * Children and adolescents patients * HBsAg seropositive Exclusion criteria: * Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C) * Prior anti-HBV therapy within 30 days of study drug dosing. Other protocol-defined inclusion/exclusion criteria may ...