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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00644761 | PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients | PHASE2 | COMPLETED | 16 | — | — | Feb 1, 2004 | May 1, 2005 | Apr 10, 2008 | 11 | United States |
| NCT01146808 | Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver | PHASE1 | COMPLETED | 16 | — | — | Mar 1, 2006 | Sep 1, 2012 | Aug 10, 2021 | 1 | United States |
| NCT00645294 | Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV | PHASE1 | COMPLETED | 47 | — | — | Feb 1, 2003 | Aug 1, 2003 | Mar 27, 2008 | 10 | Belgium, Germany +2 |
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | OTHER | Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days |
| ADV plus hepatitis B vaccination | EXPERIMENTAL | Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose. |
| Treatment Group A | OTHER | ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group B | OTHER | ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group C | OTHER | ADV 10 mg single dose on Day 1 in 12-17 year old age group |
| Name | Type | Description |
|---|---|---|
| Adefovir Dipivoxil | DRUG | Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine |
| Adefovir dipivoxil and hepatitis B vaccination | DRUG | Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose |
Inclusion Criteria: * 18-65 years of age * Greater than or equal to 6 months post-liver transplantation * Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months. * Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault meth...