| Primary | The Number of Bleeding Episodes | The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented. | The FAS included all randomised participants. | Posted | | Number | | episodes | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab- Main Part | Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated. | | OG001 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | The Number of Bleeding Episodes | The number of bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. This outcome measure is applicable for only 'Concizumab' treatment arm. | The FAS included all randomised participants. | Posted | | Number | | episodes | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab | Participants were to receive s.c. injection of concizumab once daily. In main part, the initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | The Number of Spontaneous Bleeding Episodes | Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. | Posted | | Number | | episodes | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | The Number of Spontaneous Bleeding Episodes | Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. | Posted | | Number | | episodes | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset | An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event. | The safety analysis set (SAS) included all randomised participants. | Posted | | Number | | events | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset | An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event. | The SAS included all randomised participants. Overall number of participants analysed = number of participants contributed to the analysis at the particular dose level. | Posted | | Number | | events | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration | An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred within 24 hours after eptacog alfa administration are presented. This outcome measure is applicable only for 'Eptacog alfa' treatment arm. | The SAS included all randomised participants. | Posted | | Number | | events | | Within 24 hours after eptacog alfa administration | | | | ID | Title | Description |
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| OG000 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset | Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm. | The FAS included all participants who received concizumab. | Posted | | Count of Participants | | Participants | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab- Main Part | Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated. |
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| Secondary | Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset | Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm. | The FAS included all participants who received concizumab. | Posted | | Count of Participants | | Participants | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab | Participants were to receive subcutaneous (s.c.) injection of concizumab once daily. In main part, the initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in Fibrinogen | Change in fibrinogen during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Grams per liter (g/L) | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in Fibrinogen | Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | g/L | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in D-dimer | Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in D-dimer | Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in Prothrombin Fragment 1 + 2 (F1 + 2) | Change in F1 + 2 during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Picomoles per liter (pmol/L) | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in Prothrombin Fragment 1 + 2 (F1 + 2) | Change in F1 + 2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | pmol/L | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in Prothrombin Time (PT) | Change in PT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Seconds (sec) | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in Prothrombin Time (PT) | Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | sec | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in Activated Partial Thromboplastin Time (APTT) | Change in APTT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | sec | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in Activated Partial Thromboplastin Time (APTT) | Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | sec | | During at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Change in Anti-thrombin (AT) | Change in AT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Percentage point of AT | | During at least 24 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Change in Anti-thrombin (AT) | Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | Percentage point of AT | | After at least 76 weeks from treatment onset (week 0) | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Concentration of Concizumab | Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the last dose administration at 24 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. |
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| Secondary | Concentration of Concizumab | Concentration of concizumab prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the last dose administration after atleast 76 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value | Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the last dose administration at 24 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value | Free TFPI concentration value prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the last dose administration after atleast 76 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Peak Thrombin Generation | Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Nanomoles per liter (nmol/L) | | Prior to the last dose administration at 24 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Peak Thrombin Generation | Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | nmol/L | | Prior to the last dose administration after atleast 76 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Endogenous Thrombin Potential | Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | Nanomolar*minute (nM*min) | | Prior to the last dose administration at 24 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Endogenous Thrombin Potential | Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | nM*min | | Prior to the last dose administration after atleast 76 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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| Secondary | Thrombin Generation Velocity Index | Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis. | Posted | | Mean | Standard Deviation | nM/min | | Prior to the last dose administration at 24 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg- Main Part | Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG001 | Concizumab 0.20 mg/kg- Main Part | Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. | | OG002 | Eptacog Alfa- Main Part | Participants were to receive eptacog alfa on-demand treatment for 24 weeks. |
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| Secondary | Thrombin Generation Velocity Index | Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. | The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis. | Posted | | Mean | Standard Deviation | nM/min | | Prior to the last dose administration after atleast 76 weeks | | | | ID | Title | Description |
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| OG000 | Concizumab 0.15 mg/kg | Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. | | OG001 | Concizumab 0.20 mg/kg | Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated. |
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