| Primary | Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months | 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 full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Number | | Bleeding episodes | | Month 0-6 | Bleeding episodes | Bleeding episodes | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG002 | Adolescents (12 to <18 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG003 | Adults (>=18 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
| | | Title | Denominators | Categories |
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| Excellent | | | Title | Measurements |
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| - OG00035
- OG001156
- OG00220
- OG003
|
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| |
| Secondary | Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months | The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Number | | Bleeding episodes | | Month 0-24 | Bleeding episodes | Bleeding episodes | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months | This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants, from both prophylaxis and on-demand regimen. | Posted | | Number | | Percentage of participants | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months | This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants, from both prophylaxis and on-demand regimen. | Posted | | Number | | Percentage of participants | | Month 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months | Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-6. The annualised bleeding rate was analysed by a negative binomial model. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Number | 95% Confidence Interval | Bleeding episodes/year | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | |
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| Secondary | Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months | Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-24. The annualised bleeding rate was analysed by a negative binomial model. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Number | 95% Confidence Interval | Bleeding episodes/year | | Month 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months) | Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-6 | doses | doses | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months) | Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-24 | doses | doses | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months) | Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | Injections | | Month 0-6 | bleeding episodes | bleeding episodes | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months) | Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | Injections | | Month 0-24 | bleeding episodes | bleeding episodes | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months) | Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-6 | bleeding episodes | bleeding episodes | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months) | Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-24 | bleeding episodes | bleeding episodes | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months) | Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-6 | doses | doses | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months) | Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW | | Month 0-24 | doses | doses | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months) | Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/month/participant | | Month 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months) | Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/month/participant | | Month 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months) | Preventive dose of turoctocog alfa (IU/kg body weight per year) per participant in the prophylaxis regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/year/participant | | Month 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months) | Preventive dose of turoctocog alfa (IU/kg body weight (BW) per year) per participant in the prophylaxis regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/year/participant | | Month 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months) | Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/month/participant | | Month 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months) | Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/month/participant | | Month 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months) | Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/year/participant | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months) | Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Mean | Standard Deviation | IU/kg BW/year/participant | | Month 0-24 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Frequency of Adverse Events (6 Months) | Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Number | | Events per person-year | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Frequency of Adverse Events (24 Months) | Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Number | | Events per person-year | | Month 0-24 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Frequency of Serious Adverse Events (6 Months) | Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Number | | Events per person-year | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Frequency of Serious Adverse Events (24 Months) | Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. | Posted | | Number | | Events per person-year | | Month 0-24 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months | The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Surgeries | | Month 0-6 | surgeries | surgeries | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months | The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site. Haemostatic response of 'not applicable' indicated that turoctocog alfa was not used. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Surgeries | | Month 0-24 | surgeries | surgeries | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | |
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| Secondary | Loss of Blood (Surgery): 6 Months | Loss of blood was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. "Overall Number of Units Analyzed" = number of surgeries where blood loss happened. | Posted | | Mean | Standard Deviation | mL | | Month 0-6 | surgeries with blood loss | surgeries with blood loss | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Loss of Blood (Surgery): 24 Months | Loss of blood was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. "Overall Number of Units Analyzed" = number of surgeries where blood loss happened. | Posted | | Mean | Standard Deviation | mL | | Month 0-24 | surgeries with blood loss | surgeries with blood loss | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Requirements for Transfusion (Surgery): 6 Months | Surgeries required transfusion was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Surgeries | | Month 0-6 | surgeries | surgeries | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Requirements for Transfusion (Surgery): 24 Months | Surgeries required transfusion was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Surgeries | | Month 0-24 | surgeries | surgeries | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Adverse Events (Surgery): 6 Months | TEAEs during surgery were recorded during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Events | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Adverse Events (Surgery): 24 Months | TEAEs during surgery were recorded during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Events | | Month 0-24 | | | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Serious Adverse Events (Surgery): 6 Months | Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Events | | Month 0-6 | | | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Serious Adverse Events (Surgery): 24 Months | Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period. | The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. | Posted | | Number | | Events | | Month 0-24 | | | | ID | Title | Description |
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| OG000 | Minor Surgery | Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire. | | OG001 | Major Surgery | Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered. |
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| Secondary | Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6 | Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)) and HAEM-A-QOL (for adults (>=17 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL and HAEM-A-QOL, respectively are presented. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores | | Month 0, Month 6 | | | | ID | Title | Description |
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| OG000 | Older Children (8 to 12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)). |
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| Secondary | Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24 | Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEM-A-QOL (for adults (>=17 years)) and HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)). HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEM-A-QOL and HAEMO-QOL, respectively are presented. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores | | Month 0, Month 24 | | | | ID | Title | Description |
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| OG000 | Older Children (8 to 12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)). |
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| Secondary | Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6 | Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores | | Month 0, Month 6 | | | | ID | Title | Description |
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| OG000 | Small Children (4 to 7 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24 | Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented. | The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores | | Month 0, Month 24 | | | | ID | Title | Description |
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| OG000 | Small Children (4 to 7 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Incremental Recovery of FVIII | Blood samples for the evaluation of incremental recovery of FVIII were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The incremental recovery was calculated as (FVIII: coagulant (C) activity measured in plasma 30 minutes after dosing - FVIII:C activity measured in plasma immediately before dosing)/(dose injected at time 0 minute), where the dose was expressed as IU FVIII product per kg body weight. The results are based on the chromogenic assay. | Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier pharmacokinetic (PK) profiles and/or individual plasma concentrations were excluded from the analysis. | Posted | | Mean | Standard Deviation | (IU/mL)/(IU/kg BW) | | Days 1-2 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Area Under the Curve (AUC0-inf) | Blood samples for the evaluation of AUC0-inf were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. AUC0-inf was defined as the area under the concentration versus time from time curve zero to infinity. The results are based on the chromogenic assay. | Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis. | Posted | | Mean | Standard Deviation | IU*h/mL | | Days 1-2 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) |
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| Secondary | Half-life (t½) | Blood samples for the evaluation of t½ were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay. | Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis. | Posted | | Mean | Standard Deviation | Hour (h) | | Days 1-2 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Clearance (CL) | Blood samples for the evaluation of CL were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay. | Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis. | Posted | | Mean | Standard Deviation | mL/h/kg | | Days 1-2 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. |
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| Secondary | Highest Measured FVIII Activity in the Profile (Cmax) | Blood samples for the evaluation of Cmax were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay. | Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis. | Posted | | Mean | Standard Deviation | IU/mL | | Days 1-2 | | | | ID | Title | Description |
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| OG000 | Small Children (0 to <6 Years) | Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively. | | OG001 | Older Children (6 to <12 Years) | |
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