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A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A (pathfinder8)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528551
Recruitment Status : Completed
First Posted : May 18, 2018
Results First Posted : November 26, 2021
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Bleeding Disorder
Haemophilia A
Intervention Drug: Turoctocog alfa pegol
Enrollment 160
Recruitment Details The trial was conducted at 66 sites in 25 countries: Australia(2), Brazil(1), Canada(1), Croatia(1), Denmark(1), France(2), Germany(2), Greece(1), Hungary(2), Israel(1), Italy(2), Japan(3), Korea(1), Lithuania(1), Malaysia(1), Netherlands(2), Norway(1), Portugal(1), Spain(2), Switzerland(4), Taiwan(1), Turkey(5), Ukraine(1), United Kingdom (8), United States (USA) (19).
Pre-assignment Details Out of 160 participants enrolled in this study, 102 came from trial NN7088-3859 and 58 came from trial NN7088-3885. The participants received turoctocog alfa pegol (N8-GP) injections either as once-weekly, twice weekly or three times weekly during the 104 weeks treatment period. Despite 160 participants started the trial, the total number of participants considered are 167 as 2 participants switched to twice weekly and 5 participants switched to three times weekly regimen.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 25 133 2
Completed 23 114 2
Not Completed 2 19 0
Reason Not Completed
Lost to Follow-up             0             1             0
Transferred to other arm/group             2             3             0
Withdrawal by parent/guardian             0             5             0
Protocol Violation             0             3             0
Withdrawal by Subject             0             7             0
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 25 133 2 160
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants exposed to at least one dose of trial product in the current trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 133 participants 2 participants 160 participants
35.1  (12.7) 27.3  (16.8) 25.3  (17.8) 28.4  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 133 participants 2 participants 160 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
133
 100.0%
2
 100.0%
160
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 133 participants 2 participants 160 participants
Hispanic or Latino
0
   0.0%
8
   6.0%
0
   0.0%
8
   5.0%
Not Hispanic or Latino
25
 100.0%
124
  93.2%
2
 100.0%
151
  94.4%
Unknown or Not Reported
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 133 participants 2 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  12.0%
17
  12.8%
1
  50.0%
21
  13.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
4
   3.0%
0
   0.0%
5
   3.1%
White
21
  84.0%
108
  81.2%
1
  50.0%
130
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
4
   3.0%
0
   0.0%
4
   2.5%
1.Primary Outcome
Title Number of Adverse Events Reported
Hide Description 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).
Time Frame Week 0 to week 108
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all enrolled participants who were exposed to the trial product.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Events
58 444 8
2.Secondary Outcome
Title Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU)
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Participants
0 0 0
3.Secondary Outcome
Title Number of Bleeding Episodes on Prophylaxis
Hide Description Number of bleeding episodes per participant in the prophylaxis regimen was evaluated during 104 weeks.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Episodes
123 190 14
4.Secondary Outcome
Title Number of Spontaneous Bleeding Episodes on Prophylaxis
Hide Description Spontaneous bleeding referred as bleeding episodes that occurred without apparent cause. The number of spontaneous bleeding episodes were evaluated during 104 weeks.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Episodes
98 73 8
5.Secondary Outcome
Title Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Episodes
Excellent 114 94 8
Good 8 80 6
Moderate 0 4 0
None 0 0 0
Missing 0 8 0
6.Secondary Outcome
Title Mean Number of N8-GP Injections Required Per Bleeding Episode
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Mean (Standard Deviation)
Unit of Measure: Injections per bleed
1.2  (0.6) 1.5  (1.3) 1.1  (0.4)
7.Secondary Outcome
Title Pre-dose FVIII Activity Levels on N8-GP Prophylaxis
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Mean (95% Confidence Interval)
Unit of Measure: IU/mL
0.016
(0.011 to 0.023)
0.042
(0.035 to 0.049)
0.049
(0.018 to 0.133)
8.Secondary Outcome
Title Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score)
Hide Description 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.
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 21 112 2
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.238  (7.75) -0.116  (7.40) -10.0  (14.1)
9.Secondary Outcome
Title Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Measure Type: Number
Unit of Measure: Surgeries
Excellent 3 8 0
Good 1 4 0
Moderate 0 0 0
None 0 0 0
Missing 0 1 0
10.Secondary Outcome
Title Consumption of N8-GP Per Bleed
Hide Description 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.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 10 61 3
Mean (Standard Deviation)
Unit of Measure: IU/kg/bleed
91.3  (85.0) 81.9  (55.9) 61.1  (12.0)
11.Secondary Outcome
Title Consumption of N8-GP During Prophylaxis Treatment
Hide Description The average dose of N8-GP consumed for prevention of bleed was assessed. This endpoint was evaluated from week 0 to week 104.
Time Frame Week 0 to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants exposed to at least one dose of trial product in the current trial.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 25 135 7
Mean (Standard Deviation)
Unit of Measure: IU/kg
3878  (296.4) 5320  (565.0) 7646  (877.2)
12.Secondary Outcome
Title Change From Start Till End of Trial in Treatment Satisfaction (Based on Hemo-SAT Score)
Hide Description 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.
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly
Hide Arm/Group Description:
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.
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).
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).
Overall Number of Participants Analyzed 23 118 7
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Total Score (participants aged >= 17 years) Number Analyzed 23 participants 73 participants 3 participants
-4.65  (8.16) -2.11  (7.48) -12.3  (23.78)
Total Score (participants aged <=16 years) Number Analyzed 0 participants 45 participants 4 participants
-1.78  (8.54) 1.43  (7.31)
Time Frame Week 0 to week 108
Adverse Event Reporting Description All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events 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). SAS included all enrolled participants as they were previously been exposed to trial product.
 
Arm/Group Title N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly Total
Hide Arm/Group Description 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. 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, AE data is presented for 135 participants in this arm (i.e. 133+2 = 135). 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, AE data is presented for 7 participants in this arm (i.e. 2+5 = 7). Total number of participants
All-Cause Mortality
N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      1/135 (0.74%)      0/7 (0.00%)      1/160 (0.63%)    
Hide Serious Adverse Events
N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/25 (16.00%)      15/135 (11.11%)      0/7 (0.00%)      19/160 (11.88%)    
Hepatobiliary disorders         
Cholecystitis † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Infections and infestations         
Arthritis bacterial † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Subcutaneous abscess † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Injury, poisoning and procedural complications         
Humerus fracture † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Procedural haemorrhage † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Road traffic accident † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Skin laceration † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Traumatic haemorrhage † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Wound secretion † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Musculoskeletal and connective tissue disorders         
Arthropathy † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Intervertebral disc protrusion † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Osteoarthritis † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Melanocytic naevus † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Squamous cell carcinoma of the tongue † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Nervous system disorders         
Cervical radiculopathy † 1  1/25 (4.00%)  1 0/135 (0.00%)  0 0/7 (0.00%)  0 1/160 (0.63%)  1
Presyncope † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Seizure † 1  0/25 (0.00%)  0 3/135 (2.22%)  3 0/7 (0.00%)  0 3/160 (1.88%)  3
Psychiatric disorders         
Depression suicidal † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
Surgical and medical procedures         
Mole excision † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 0/7 (0.00%)  0 1/160 (0.63%)  1
1
Term from vocabulary, MedDRA 23
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
N8-GP, Once Weekly N8-GP, Twice Weekly N8-GP, Three Times Weekly Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/25 (36.00%)      46/135 (34.07%)      4/7 (57.14%)      56/160 (35.00%)    
Gastrointestinal disorders         
Dental caries † 1  3/25 (12.00%)  3 0/135 (0.00%)  0 0/7 (0.00%)  0 3/160 (1.88%)  3
Infections and infestations         
Influenza † 1  0/25 (0.00%)  0 9/135 (6.67%)  9 0/7 (0.00%)  0 9/160 (5.63%)  9
Nasopharyngitis † 1  3/25 (12.00%)  3 21/135 (15.56%)  23 0/7 (0.00%)  0 24/160 (15.00%)  26
Upper respiratory tract infection † 1  4/25 (16.00%)  13 11/135 (8.15%)  18 1/7 (14.29%)  2 16/160 (10.00%)  33
Injury, poisoning and procedural complications         
Fall † 1  0/25 (0.00%)  0 3/135 (2.22%)  3 1/7 (14.29%)  1 3/160 (1.88%)  4
Metabolism and nutrition disorders         
Vitamin B12 deficiency † 1  2/25 (8.00%)  2 0/135 (0.00%)  0 0/7 (0.00%)  0 2/160 (1.25%)  2
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  2/25 (8.00%)  2 11/135 (8.15%)  12 1/7 (14.29%)  1 14/160 (8.75%)  15
Limb discomfort † 1  0/25 (0.00%)  0 0/135 (0.00%)  0 1/7 (14.29%)  1 1/160 (0.63%)  1
Nervous system disorders         
Headache † 1  0/25 (0.00%)  0 10/135 (7.41%)  11 0/7 (0.00%)  0 10/160 (6.25%)  11
Psychiatric disorders         
Attention deficit hyperactivity disorder † 1  0/25 (0.00%)  0 0/135 (0.00%)  0 1/7 (14.29%)  1 1/160 (0.63%)  1
Depression † 1  0/25 (0.00%)  0 1/135 (0.74%)  1 2/7 (28.57%)  2 3/160 (1.88%)  3
1
Term from vocabulary, MedDRA 23
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Transparency Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03528551    
Other Study ID Numbers: NN7088-4410
U1111-1202-2780 ( Other Identifier: World Health Organization (WHO) )
2017-003788-36 ( Registry Identifier: European Medicines Agency (EudraCT) )
JapicCTI-183952 ( Registry Identifier: JAPIC )
First Submitted: April 18, 2018
First Posted: May 18, 2018
Results First Submitted: July 22, 2021
Results First Posted: November 26, 2021
Last Update Posted: December 22, 2022