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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00837356 | Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects | PHASE1 | COMPLETED | 23 | — | — | Mar 1, 2009 | Oct 1, 2009 | Feb 10, 2017 | 7 | Germany, Israel +3 |
| Arm | Type | Description |
|---|---|---|
| Advate®/turoctocog alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Advate® | DRUG | Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session |
| turoctocog alfa | DRUG | After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session |
Inclusion Criteria: * Severe haemophilia A (FVIII level less than or equal to 1%) * Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products * HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the en...