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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02938585 | Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A | PHASE3 | COMPLETED | 68 | — | — | Dec 12, 2016 | Dec 12, 2018 | Jul 27, 2020 | 11 | China |
| NCT01493778 | Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A | PHASE3 | COMPLETED | 60 | — | — | Sep 17, 2012 | Dec 5, 2018 | Nov 30, 2020 | 69 | United States, Algeria +16 |
| NCT01138501 | Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A | PHASE3 | COMPLETED | 65 | — | — | Jun 1, 2010 | Nov 1, 2011 | Mar 17, 2017 | 38 | United States, Brazil +11 |
| NCT00984126 | Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 | PHASE3 | COMPLETED | 214 | — | — | Oct 26, 2009 | Jun 29, 2016 | Jul 27, 2017 | 57 | United States, Brazil +18 |
| NCT00840086 | Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects | PHASE3 | COMPLETED | 150 | — | — | Apr 1, 2009 | Sep 1, 2011 | Mar 17, 2017 | 63 | United States, Brazil +16 |
| NCT02941354 | Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A | PHASE1 | COMPLETED | 35 | — | — | Oct 10, 2016 | Jun 20, 2017 | Jan 30, 2019 | 15 | United States, Austria +5 |
| NCT01692925 | Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A | PHASE1 | COMPLETED | 15 | — | — | Dec 1, 2012 | Mar 1, 2013 | Feb 10, 2017 | 5 | Germany, Latvia +2 |
| NCT01365520 | A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A | PHASE1 | COMPLETED | 4 | — | — | Jun 1, 2011 | Sep 1, 2011 | Feb 10, 2017 | 3 | Malaysia, United Kingdom |
| NCT01238367 | A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 | PHASE1 | COMPLETED | 6 | — | — | Nov 1, 2010 | Oct 1, 2011 | Feb 10, 2017 | 6 | Japan |
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 * ...