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Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B. (paradigm™5)

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ClinicalTrials.gov Identifier: NCT01467427
Recruitment Status : Active, not recruiting
First Posted : November 8, 2011
Results First Posted : November 17, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Bleeding Disorder
Haemophilia B
Intervention Drug: nonacog beta pegol
Enrollment 25
Recruitment Details Of the 19 sites that screened subjects, 17 sites enrolled subjects. The trial was therefore conducted at 17 sites in 8 countries, as follows: Canada: 1 site; Germany: 1 site; Italy: 1 site; Japan: 3 sites; Malaysia: 1 site; Taiwan: 1 site; United Kingdom: 3 sites; United States: 6 sites
Pre-assignment Details  
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg. Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Period Title: Overall Study
Started 12 13
Completed Main Phase 11 13
Completed 0 0
Not Completed 12 13
Reason Not Completed
Withdrawal by Subject             1             0
Entered extension phase             11             11
Not continuing in extension phase             0             2
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years) Total
Hide Arm/Group Description Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg. Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg. Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
3.1  (1.7) 9.6  (1.6) 6.5  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
13
 100.0%
25
 100.0%
1.Primary Outcome
Title Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
Hide Description Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
Time Frame From 0 to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all subjects exposed to nonacog beta pegol
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: Number of subjects
0 0
2.Primary Outcome
Title Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
Hide Description [Not Specified]
Time Frame From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Bleeding Episodes During Prophylaxis
Hide Description The number of bleeding episodes per subject during routine prophylaxis was assessed using the individual annualised bleeding rates (bleeding episodes per subject per year).
Time Frame From 0 to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all subject with efficacy data after exposure to nonacog beta pegol.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 12 13
Median (Inter-Quartile Range)
Unit of Measure: bleeds/subject/year
0.00
(0.00 to 1.78)
2.00
(0.68 to 2.89)
4.Secondary Outcome
Title Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
Hide Description

Description of the haemostatic effect of nonacog beta pegol when used for treatment of bleeding episodes was measured and listed according to the four point scale for haemostatic response as below:

  1. Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion.
  2. Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection.
  3. Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours.
  4. Poor – no improvement, or worsening of symptoms within 8 hours after two injections.

A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.

Time Frame From 0 to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of subjects analysed=subjects who experienced bleeding episodes.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 5 10
Measure Type: Number
Unit of Measure: percentage of bleeding episodes
Success 90.9 93.5
Failure 9.1 6.5
5.Secondary Outcome
Title Incremental Recovery at 30 Minutes (IR30min)
Hide Description The incremental recovery was calculated by dividing the baseline-subtracted factor IX activity (U/mL) measured in plasma 30 min after dosing by the dose injected at time 0 expressed as U/kg body weight.
Time Frame Week 0 (30 minutes after first exposure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (U/mL)/(U/kg)
0.015
(7.31%)
0.016
(16.18%)
6.Secondary Outcome
Title Trough Level (Single-dose )
Hide Description The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Geometric mean of the lowest activity of factor IX recorded at week 0 (immediately before next dose was given).
Time Frame Week 0 (one week after first exposure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 11 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: U/mL
0.084
(16.28%)
0.109
(18.89%)
7.Secondary Outcome
Title Trough Level (Steady State)
Hide Description The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. The estimated mean of the lowest activity recorded immediately before next dose was given from week 4 to week 52. The analysis is based on a mixed model on the log-transformed plasma concentrations with subject as a random effect and the mean trough level is presented back-transformed to the natural scale.
Time Frame Week 4 to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 12 13
Mean (95% Confidence Interval)
Unit of Measure: U/mL
0.154
(0.127 to 0.186)
0.190
(0.159 to 0.228)
8.Secondary Outcome
Title Terminal Half-life (t1/2)
Hide Description [Not Specified]
Time Frame Week 0 (30 minutes until one week after first exposure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title Younger Children (0-6 Years) Older Children (7-12 Years)
Hide Arm/Group Description:
Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
Overall Number of Participants Analyzed 12 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
69.576
(15.79%)
76.323
(25.48%)
9.Secondary Outcome
Title Number of Bleeding Episodes During Prophylaxis
Hide Description [Not Specified]
Time Frame From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Trough Level (Steady State)
Hide Description [Not Specified]
Time Frame From week 52 until the patient has completed the trial (no later than 31-Oct-2018)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
Hide Description [Not Specified]
Time Frame From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)
Outcome Measure Data Not Reported
Time Frame Week 0 to week 52
Adverse Event Reporting Description The analysis was based on safety analysis set. Treatment emergent AEs were defined as AEs occurring after dosing with trial product.
 
Arm/Group Title Younger Children (0 - 6 Years) Older Children (7 - 12 Years)
Hide Arm/Group Description Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg. Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
All-Cause Mortality
Younger Children (0 - 6 Years) Older Children (7 - 12 Years)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Younger Children (0 - 6 Years) Older Children (7 - 12 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/13 (7.69%)    
Gastrointestinal disorders     
Food poisoning  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Younger Children (0 - 6 Years) Older Children (7 - 12 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      12/13 (92.31%)    
Blood and lymphatic system disorders     
Eosinophilia  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Ear and labyrinth disorders     
Ear pain  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Eye disorders     
Periorbital oedema  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Abdominal pain  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Abdominal pain upper  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Chapped lips  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Dental caries  1  0/12 (0.00%)  0 2/13 (15.38%)  2
Diarrhoea  1  3/12 (25.00%)  3 1/13 (7.69%)  1
Dyspepsia  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Faeces discoloured  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Flatulence  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Lip swelling  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Nausea  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Vomiting  1  2/12 (16.67%)  6 2/13 (15.38%)  4
General disorders     
Inflammation  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Infusion site pain  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Injection site pain  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Local swelling  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Pain  1  0/12 (0.00%)  0 1/13 (7.69%)  3
Pyrexia  1  4/12 (33.33%)  11 2/13 (15.38%)  3
Swelling  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Immune system disorders     
Seasonal allergy  1  3/12 (25.00%)  3 1/13 (7.69%)  1
Infections and infestations     
Acute tonsillitis  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Bronchitis  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Conjunctivitis  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Croup infectious  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Diarrhoea infectious  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Ear infection  1  2/12 (16.67%)  2 0/13 (0.00%)  0
Empyema  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Gastroenteritis  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Gingivitis  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Hordeolum  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Influenza  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Lower respiratory tract infection  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Molluscum contagiosum  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Nasopharyngitis  1  4/12 (33.33%)  9 1/13 (7.69%)  2
Otitis externa  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Otitis media  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Pharyngitis  1  2/12 (16.67%)  2 2/13 (15.38%)  2
Pharyngitis streptococcal  1  1/12 (8.33%)  1 2/13 (15.38%)  2
Rhinitis  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Streptococcal infection  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Upper respiratory tract infection  1  2/12 (16.67%)  3 3/13 (23.08%)  4
Varicella  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications     
Accident  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Arthropod bite  1  2/12 (16.67%)  2 0/13 (0.00%)  0
Contusion  1  2/12 (16.67%)  4 6/13 (46.15%)  13
Excoriation  1  3/12 (25.00%)  4 2/13 (15.38%)  6
Eye injury  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Fall  1  2/12 (16.67%)  2 1/13 (7.69%)  1
Head injury  1  2/12 (16.67%)  7 2/13 (15.38%)  2
Injury  1  1/12 (8.33%)  1 2/13 (15.38%)  2
Joint dislocation  1  1/12 (8.33%)  2 0/13 (0.00%)  0
Joint injury  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Laceration  1  1/12 (8.33%)  1 1/13 (7.69%)  2
Ligament sprain  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Limb injury  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Lip injury  1  2/12 (16.67%)  3 0/13 (0.00%)  0
Post-traumatic pain  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Radius fracture  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Tooth avulsion  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Wound  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Investigations     
International normalised ratio increased  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Lymph node palpable  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Prothrombin time prolonged  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Varicella virus test positive  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/12 (0.00%)  0 3/13 (23.08%)  5
Groin pain  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Growing pains  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Haemarthrosis  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Musculoskeletal pain  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Myalgia  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Pain in extremity  1  1/12 (8.33%)  1 2/13 (15.38%)  6
Nervous system disorders     
Dizziness  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Headache  1  0/12 (0.00%)  0 3/13 (23.08%)  7
Reproductive system and breast disorders     
Penile discharge  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Penile pain  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/12 (58.33%)  14 3/13 (23.08%)  3
Epistaxis  1  2/12 (16.67%)  2 0/13 (0.00%)  0
Nasal congestion  1  1/12 (8.33%)  2 0/13 (0.00%)  0
Oropharyngeal pain  1  2/12 (16.67%)  3 1/13 (7.69%)  2
Rhinitis allergic  1  1/12 (8.33%)  3 0/13 (0.00%)  0
Rhinorrhoea  1  2/12 (16.67%)  7 1/13 (7.69%)  1
Wheezing  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Dry skin  1  0/12 (0.00%)  0 1/13 (7.69%)  2
Haemorrhage subcutaneous  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Miliaria  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Nail disorder  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Rash  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Urticaria  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Vascular disorders     
Hypotension  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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 manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Results Point of Contact
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
Other Publications:
Safety, efficacy and pharmacokinetics of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously treated pediatric hemophilia B patients. Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu M-Y, Persson P, Rangarajan S, Santagostino E. Presented 06-Dec-2014 at the American Society of Hematology - 56th Annual Meeting - held in San Francisco, CA, US (poster #1513)
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467427     History of Changes
Other Study ID Numbers: NN7999-3774
2011-000826-31 ( EudraCT Number )
U1111-1119-5013 ( Other Identifier: WHO )
JapicCTI- 121877 ( Registry Identifier: JAPIC )
First Submitted: October 31, 2011
First Posted: November 8, 2011
Results First Submitted: June 21, 2017
Results First Posted: November 17, 2017
Last Update Posted: August 2, 2018