| Primary | Number of Adverse Events Reported | An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAEs). The TEAE is defined as an event reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). | Safety analysis set (SAS) included all enrolled participants who were exposed to the trial product. | Posted | | Number | | Events | | Week 0 to week 108 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). | | OG002 | N8-GP, Three Times Weekly | Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7). |
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| Secondary | Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | The Incidence of inhibitors against coagulation factor eight (FVIII) is defined as titre greater than or equal to (≥) 0.6 Bethesda unit. The inhibitor antibodies were measured using a heat modified Nijmegen FVIII Bethesda assay. The number of participants who developed inhibitors against FVIII are reported. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Number | | Participants | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Number of Bleeding Episodes on Prophylaxis | Number of bleeding episodes per participant in the prophylaxis regimen was evaluated during 104 weeks. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Number | | Episodes | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Number of Spontaneous Bleeding Episodes on Prophylaxis | Spontaneous bleeding referred as bleeding episodes that occurred without apparent cause. The number of spontaneous bleeding episodes were evaluated during 104 weeks. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Number | | Episodes | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None | The haemostatic effect after treatment of a bleed with N8-GP was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection. 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection; usually requiring more than one injection 4. None: No improvement or worsening of symptoms. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Number | | Episodes | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 |
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| Secondary | Mean Number of N8-GP Injections Required Per Bleeding Episode | The mean number of N8-GP injections required per bleeding episode from start to stop of a bleed for participants was presented from week 0 to week 104. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Mean | Standard Deviation | Injections per bleed | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Pre-dose FVIII Activity Levels on N8-GP Prophylaxis | The pre-dose FVIII activity levels were assessed in International units per millilitre (IU/mL) units from week 0 to week 104 to get an estimate of the pre-dose level for N8-GP at steady-state using mixed model. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Mean | 95% Confidence Interval | IU/mL | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score) | Haemophilia Joint Health Score is a validated outcome tool developed for the assessment of joint health in patients with hemophilia. It comprises an evaluation of the elbow, knee and ankle joints with regards to swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. Higher the score higher the joint damage). Change from week 0 to end of trial (week 104) in the domain scores was presented. | FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, Week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | |
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| Secondary | Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None | The Haemostatic response to N8-GP during major surgical interventions was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen 4. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. This endpoint was measured from week 0 to week 104. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Number | | Surgeries | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | |
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| Secondary | Consumption of N8-GP Per Bleed | The average dose of N8-GP consumed for treatment of bleed was assessed in International units per kilogram per bleed(IU/kg/bleed). This endpoint was evaluated from week 0 to week 104. | FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | IU/kg/bleed | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Consumption of N8-GP During Prophylaxis Treatment | The average dose of N8-GP consumed for prevention of bleed was assessed. This endpoint was evaluated from week 0 to week 104. | FAS included all participants exposed to at least one dose of trial product in the current trial. | Posted | | Mean | Standard Deviation | IU/kg | | Week 0 to week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | | OG001 | N8-GP, Twice Weekly | Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135). |
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| Secondary | Change From Start Till End of Trial in Treatment Satisfaction (Based on Hemo-SAT Score) | The treatment satisfaction of a bleed with N8-GP was assessed using HEMO-SAT assessment tool which contains a questionnaire with 6 domains (Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction), with a scale of 0-100. The lower scores reflecting greater treatment satisfaction. In other words, decrease in the score would mean improvement. The summary of change presented was based on individual changes since week 0. Data is presented for total score. | FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. Number analysed = Number of participants who contributed to the analysis. In the N8-GP, once weekly arm; none of the subjects were aged <=16 years. Hence the number analyzed is mentioned as zero. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, Week 104 | | | | ID | Title | Description |
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| OG000 | N8-GP, Once Weekly | Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization. | |
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