Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
turoctocog alfa · 9 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 | - |
| 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. |
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 for congenital bleeding disorder, specifically haemophilia A. It is an investigational therapy being developed by Novo Nordisk A/S (NVO) and is currently in Phase 3 clinical development. The drug is being studied in patients with haemophilia A, a condition characterized by a deficiency in clotting factor VIII.
Turoctocog alfa targets factor VIII, a protein essential for blood clotting. It is a recombinant factor VIII product designed to replace the missing or deficient factor VIII in patients with haemophilia A. By providing this clotting factor, the drug aims to help control and prevent bleeding episodes in affected individuals.
Turoctocog alfa is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of congenital bleeding disorder, specifically haemophilia A.
Turoctocog alfa is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of congenital bleeding disorder, with a focus on haemophilia A, and has completed nine clinical trials to date.
Turoctocog alfa has been studied in several clinical trials, including NCT01238367, NCT01365520, NCT01692925, and NCT02941354. These trials have investigated the drug's pharmacokinetics and safety in patients with haemophilia A. All nine trials have been completed, with a total enrollment of 617 participants across various countries.
Yes, turoctocog alfa is also known as NovoEight. The drug is marketed under the brand name NovoEight and is being developed by Novo Nordisk for the treatment of haemophilia A. Clinical trials, such as NCT02941354, have evaluated the pharmacokinetics of NovoEight (turoctocog alfa) in relation to body mass index in subjects with haemophilia A.