Phase 3
Completed N=68
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Congenital Bleeding Disorder · Hemophilia A
Source: ClinicalTrials.gov NCT02938585 ↗
Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Aug 2019
Primary outcomePrimary: Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months — 35; 156; 20; 190 Bleeding episodes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months |
35; 156; 20; 190; 12; 73 | — |
| SECONDARY Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months |
45; 275; 42; 272; 18; 103 | — |
| SECONDARY Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months |
0; 0; 0; 0 | — |
| SECONDARY Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months |
0; 0; 0; 0 | — |
| SECONDARY Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months |
4.36; 4.11; 2.34; 10.67 | — |
| SECONDARY Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months |
2.28; 2.63; 1.97; 4.97 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months) |
42.96; 36.69; 46.79; 20.29 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months) |
43.99; 36.00; 43.58; 21.07 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months) |
1.31; 1.22; 1.07; 1.29 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months) |
1.34; 1.30; 1.09; 1.33 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months) |
56.60; 42.37; 48.82; 26.20 | — |
| SECONDARY Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months) |
59.01; 44.75; 45.07; 27.44 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months) |
47.05; 39.46; 35.40; 37.28 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months) |
47.97; 40.33; 36.20; 38.13 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months) |
600.3; 522.5; 454.5; 500.7 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months) |
606.3; 533.0; 467.6; 490.8 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months) |
7204; 6270; 5454; 6009 | — |
| SECONDARY Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months) |
7276; 6396; 5611; 5890 | — |
| SECONDARY Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months) |
603.5; 496.0; 479.6; 377.2 | — |
| SECONDARY Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months) |
615.3; 516.7; 477.0; 429.1 | — |
| SECONDARY Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months) |
7242; 5951; 5756; 4527 | — |
| SECONDARY Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months) |
7384; 6201; 5724; 5149 | — |
| SECONDARY Frequency of Adverse Events (6 Months) |
4.908; 2.093; 2.325; 1.922 | — |
| SECONDARY Frequency of Adverse Events (24 Months) |
2.941; 1.210; 1.074; 1.123 | — |
| SECONDARY Frequency of Serious Adverse Events (6 Months) |
0; 0; 0.634; 0 | — |
| SECONDARY Frequency of Serious Adverse Events (24 Months) |
0.065; 0; 0.161; 0 | — |
| SECONDARY Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months |
2; 1; 1; 2; 0; 0 | — |
| SECONDARY Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months |
3; 1; 1; 3; 0; 0 | — |
| SECONDARY Loss of Blood (Surgery): 6 Months |
2.0; 106.7 | — |
| SECONDARY Loss of Blood (Surgery): 24 Months |
2.0; 81.3 | — |
| SECONDARY Requirements for Transfusion (Surgery): 6 Months |
0; 0 | — |
| SECONDARY Requirements for Transfusion (Surgery): 24 Months |
0; 0 | — |
| SECONDARY Adverse Events (Surgery): 6 Months |
1; 1 | — |
| SECONDARY Adverse Events (Surgery): 24 Months |
4; 1 | — |
| SECONDARY Serious Adverse Events (Surgery): 6 Months |
0; 0 | — |
| SECONDARY Serious Adverse Events (Surgery): 24 Months |
0; 0 | — |
| SECONDARY Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6 |
41.3; 42.2; 47.2; -6.8; -3.5; -3.4 | — |
| SECONDARY Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24 |
41.3; 42.2; 47.2; -10.1; -4.9; -6.3 | — |
| SECONDARY Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6 |
45.7; 48.3; 40.8; -6.2; -9.9; -1.5 | — |
| SECONDARY Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24 |
45.7; 48.3; 40.8; -6.7; -11.3; -3.1 | — |
| SECONDARY Incremental Recovery of FVIII |
0.022; 0.026; 0.014; 0.026 | — |
| SECONDARY Area Under the Curve (AUC0-inf) |
16.4; 17.7; 11.2; 16.9 | — |
| SECONDARY Half-life (t½) |
8.5; 8.3; 11.6; 8.4 | — |
| SECONDARY Clearance (CL) |
3.7; 3.5; 5.5; 3.5 | — |
| SECONDARY Highest Measured FVIII Activity in the Profile (Cmax) |
1.2; 1.4; 0.9; 1.6 | — |
Eligibility Criteria
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
- Patients below 12 years: 50 exposure days (ED) or more
Exclusion Criteria
- Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
- Known history of FVIII inhibitors
Data sourced from ClinicalTrials.gov (NCT02938585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.