Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as N8, recombinant factor VIII, recombinant FVIII
turoctocog alfa · 10 trials · 2 indications
The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.
The incidence rate (percentage of participants with inhibitors) of inhibitors defined as inhibitor titres ≥0.6 BU for main phase of the trial.
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.
Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose
| Arm | Type | Description |
|---|---|---|
| Prophylactic treatment | EXPERIMENTAL | - |
| On-demand treatment | EXPERIMENTAL | - |
| turoctocog alfa | EXPERIMENTAL | - |
| rFVIII | EXPERIMENTAL | - |
| Lot A | EXPERIMENTAL | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot B | EXPERIMENTAL | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot C | EXPERIMENTAL | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot D | EXPERIMENTAL | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| N8 | EXPERIMENTAL | - |
| recombinant factor VIII (N8) | EXPERIMENTAL | - |
| Advate®/turoctocog alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| turoctocog alfa | DRUG | The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur. |
| Advate® | DRUG | Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session |
Inclusion Criteria: * Male patients * Age from 0 years * With the diagnosis of severe congenital haemophilia A (FVIII≤1%) * History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients: * Patients of 12 years or above: 100 exposures days (ED) or more * ...
Turoctocog alfa is used to prevent and treat bleeding episodes in people with congenital bleeding disorder, specifically haemophilia A. It is a recombinant factor VIII therapy developed for previously treated and previously untreated patients, including children, and is studied for prophylaxis and on-demand treatment of bleeds.
Turoctocog alfa targets factor VIII, encoded by the F8 gene. It is an exogenous protein that replaces missing or defective factor VIII, the clotting protein absent or dysfunctional in haemophilia A, thereby supporting normal blood coagulation and controlling or preventing bleeding episodes.
Turoctocog alfa is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical trial program evaluating the drug in haemophilia A and other congenital bleeding disorders.
Turoctocog alfa has completed Phase 3 clinical development. Ten trials are registered, all completed, including Phase 1 pharmacokinetic studies and Phase 3 safety and efficacy studies. It is an investigational product in the context of these trials and is not described as approved in the available data.
Turoctocog alfa has been studied in completed trials including NCT02941354, a Phase 1 pharmacokinetic study in relation to BMI; NCT02938585, a Phase 3 efficacy and safety study in Chinese patients; NCT01692925, a Phase 1 pharmacokinetic study; and NCT01493778, a Phase 3 study in previously untreated children.
Yes, turoctocog alfa is also known as NovoEight. NovoEight is the brand name used for turoctocog alfa, a recombinant factor VIII product developed by Novo Nordisk for the treatment of haemophilia A and congenital bleeding disorder.