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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00426712 | Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients | PHASE1 | COMPLETED | 42 | — | — | Jan 1, 2006 | Mar 1, 2008 | Mar 20, 2019 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Low dose |
| 2 | EXPERIMENTAL | Middle dose |
| 3 | EXPERIMENTAL | High dose |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen | BIOLOGICAL | Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8 |
| Hepatitis B Vaccine (Recombinant) | BIOLOGICAL | IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24 |
Inclusion Criteria: * Willing and able to give written informed consent * Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis * Body ...