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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia B

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
nonacog beta pegol
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

0 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records
  • Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
  • Body weight above or equal to 10 kg
  • History of at least 50 exposure days (EDs) to other FIX products
  • The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures

Exclusion Criteria:

  • Known history of FIX inhibitors
  • Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)
  • Congenital or acquired coagulation disorder other than haemophilia B
  • Platelet count below 50,000/mcL at screening
  • Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening
  • Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening
  • Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL
  • Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
  • Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NNC-0156-000-0009

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
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.
Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)

Secondary Outcome Measures

Number of Bleeding Episodes During Prophylaxis
The number of bleeding episodes per subject during routine prophylaxis was assessed using the individual annualised bleeding rates (bleeding episodes per subject per year).
Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
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: Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion. Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection. Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours. 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.
Incremental Recovery at 30 Minutes (IR30min)
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.
Trough Level (Single-dose )
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).
Trough Level (Steady State)
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.
Terminal Half-life (t1/2)
Number of Bleeding Episodes During Prophylaxis
Trough Level (Steady State)
Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
Number of Adverse Events
An adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Serious Adverse Events (SAEs)
A SAE was an experience that at any dose resulted in any of the following: death, a life-threatening experience a), In-patient hospitalisation or prolongation of existing hospitalisation b) a persistent or significant disability/incapacity c) a congenital anomaly/birth defect, Important medical events d) that did not result in death, were life-threatening a) or required hospitalization.
Medical Events of Special Interest (MESI)
The following events were defined as MESIs: -Medication errors concerning trial products, -Administration of wrong drug, Wrong route of administration, Administration of a high dose with the intention to cause harm, e.g. suicide attempt, Administration of an accidental overdose: more than 20 % from the intended dose, Inhibitor formation against factor IX (FIX), Thromboembolic events, Anaphylactic reaction. Allergic reaction including, but not limited to, any acute immunoglobulin E (IgE) mediated reaction or delayed type hypersensitivity.
Development of Host Cell Protein (HCP) Antibodies
Participants were examined for the development of antibodies against HCP. Number of participants who developed antibodies against HCP is presented.
FIX Consumption Described as Frequency of Dose/kg for Prophylaxis Use for the Treatment of Bleeding Episodes
Consumption of nonacog beta pegol for treatment of bleeding episodes per year per patient is presented.
FIX Consumption Described as Amount Consumed for the Treatment of Bleeding Episodes
Average dose of nonacog beta pegol for treatment of bleed from start to stop of bleed is presented.
Number of Doses of FIX Consumed for the Treatment of Bleeding Episodes
Number of doses of FIX consumed for the treatment of bleeding episodes is presented.
Area Under the Curve Activity Versus Time Profile From Time Zero to 168 Hours Post Dose (AUC(0-168))
Area under the curve activity versus time profile from time zero to 168 hours post dose of nonacog beta pegol is presented.
Clearance (CL)
Clearance of nonacog beta pegol after single dose is presented.
Mean Residence Time (MRT)
Mean residence time (MRT) of nonacog beta pegol after single dose is presented.
Volume of Distribution at Steady State (Vss)
Volume of distribution at steady state (Vss) of nonacog beta pegol is presented.
FIX Activity at 30 Minutes (C30min) (Single Dose)
FIX activity (international units per milliliter (IU/mL))at 30 minutes after single dose is presented.
FIX Activity at 30 Minutes (C30min) (Steady State)
Mean FIX activity at 30 minutes post-dosing from 4 to 52 weeks (C30min) (steady state) is presented.
TNO-AZL Preschool Quality of Life (TAPQOL)
The Dutch institute of Prevention and Health and the Leiden University Hospital (TNO-AZL) preschool quality of life clustered into 12 multi-item scales is used to assess the health-related quality of life, such as children's motor, communication, emotions, and body structure. Suitable for children from 6 months to 6 years old (TAPQOL). Parents fill in according to the child's condition. Higher score (range 0-100) represent better outcome. In this study, the TAPQOL was assessed for children of age 0-3 years.
Health Economic Impact of N9-GP Treatment Through Characterisation of General Hospitalisation
Health economic impact of N9-GP treatment is presented through number of general hospitalization days.
Health Economic Impact of N9-GP Treatment Through Characterisation of Intensive Care Hospitalisation
Health economic impact of N9-GP treatment is presented through number of intensive care hospitalization days.
Health Economic Impact of N9-GP Treatment Through Characterisation of Bleedings Caused Missing School or Studies
Health economic impact of N9-GP treatment through number of days bleedings caused missing school or studies. Number of participants who missed school or studies for 0,1 and 2 days are presented.
Health Economic Impact of N9-GP Treatment Through Characterisation of Number of Days Bleedings Caused Using of Mobility Aids
Health economic impact of N9-GP treatment through number of days the patient used mobility aids (wheelchair and/or crutches) is presented.
Health Economic Impact of N9-GP Treatment Through Characterisation of Number of Days Bleedings Caused Parents to Miss Work
Health economic impact of N9-GP treatment through number of days bleedings caused parents to miss work is presented.

Full Information

First Posted
October 31, 2011
Last Updated
April 17, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01467427
Brief Title
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Acronym
paradigmâ„¢5
Official Title
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2012 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC-0156-000-0009
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nonacog beta pegol
Other Intervention Name(s)
NNC-0156-0000-0009
Intervention Description
A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.
Primary Outcome Measure Information:
Title
Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
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
Title
Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
Time Frame
From week 52 until the last patient has completed the trial (no later than 30-Nov-2023)
Secondary Outcome Measure Information:
Title
Number of Bleeding Episodes During Prophylaxis
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
Title
Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
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: Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion. Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection. Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours. 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
Title
Incremental Recovery at 30 Minutes (IR30min)
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)
Title
Trough Level (Single-dose )
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)
Title
Trough Level (Steady State)
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
Title
Terminal Half-life (t1/2)
Time Frame
Week 0 (30 minutes until one week after first exposure)
Title
Number of Bleeding Episodes During Prophylaxis
Time Frame
From week 52 until the last patient has completed the trial (no later than 30-Nov-2023)
Title
Trough Level (Steady State)
Time Frame
From week 52 until the patient has completed the trial (no later than 30-Nov-2023)
Title
Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)
Time Frame
From week 52 until the last patient has completed the trial (no later than 30-Nov-2023)
Title
Number of Adverse Events
Description
An adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
From 0 to 52 weeks
Title
Number of Serious Adverse Events (SAEs)
Description
A SAE was an experience that at any dose resulted in any of the following: death, a life-threatening experience a), In-patient hospitalisation or prolongation of existing hospitalisation b) a persistent or significant disability/incapacity c) a congenital anomaly/birth defect, Important medical events d) that did not result in death, were life-threatening a) or required hospitalization.
Time Frame
From 0 to 52 weeks
Title
Medical Events of Special Interest (MESI)
Description
The following events were defined as MESIs: -Medication errors concerning trial products, -Administration of wrong drug, Wrong route of administration, Administration of a high dose with the intention to cause harm, e.g. suicide attempt, Administration of an accidental overdose: more than 20 % from the intended dose, Inhibitor formation against factor IX (FIX), Thromboembolic events, Anaphylactic reaction. Allergic reaction including, but not limited to, any acute immunoglobulin E (IgE) mediated reaction or delayed type hypersensitivity.
Time Frame
From 0 to 52 weeks
Title
Development of Host Cell Protein (HCP) Antibodies
Description
Participants were examined for the development of antibodies against HCP. Number of participants who developed antibodies against HCP is presented.
Time Frame
From 0 to 52 weeks
Title
FIX Consumption Described as Frequency of Dose/kg for Prophylaxis Use for the Treatment of Bleeding Episodes
Description
Consumption of nonacog beta pegol for treatment of bleeding episodes per year per patient is presented.
Time Frame
From 0 to 52 weeks
Title
FIX Consumption Described as Amount Consumed for the Treatment of Bleeding Episodes
Description
Average dose of nonacog beta pegol for treatment of bleed from start to stop of bleed is presented.
Time Frame
From 0 to 52 weeks
Title
Number of Doses of FIX Consumed for the Treatment of Bleeding Episodes
Description
Number of doses of FIX consumed for the treatment of bleeding episodes is presented.
Time Frame
From 0 to 52 weeks
Title
Area Under the Curve Activity Versus Time Profile From Time Zero to 168 Hours Post Dose (AUC(0-168))
Description
Area under the curve activity versus time profile from time zero to 168 hours post dose of nonacog beta pegol is presented.
Time Frame
0-168 hours post-dosing at week 0
Title
Clearance (CL)
Description
Clearance of nonacog beta pegol after single dose is presented.
Time Frame
0-168 hours post-dosing at week 0
Title
Mean Residence Time (MRT)
Description
Mean residence time (MRT) of nonacog beta pegol after single dose is presented.
Time Frame
0-168 hours post-dosing at week 0
Title
Volume of Distribution at Steady State (Vss)
Description
Volume of distribution at steady state (Vss) of nonacog beta pegol is presented.
Time Frame
0-168 hours post-dosing at week 0
Title
FIX Activity at 30 Minutes (C30min) (Single Dose)
Description
FIX activity (international units per milliliter (IU/mL))at 30 minutes after single dose is presented.
Time Frame
30 min post-dosing at week 0
Title
FIX Activity at 30 Minutes (C30min) (Steady State)
Description
Mean FIX activity at 30 minutes post-dosing from 4 to 52 weeks (C30min) (steady state) is presented.
Time Frame
30 min post-dosing from 4 to 52 weeks
Title
TNO-AZL Preschool Quality of Life (TAPQOL)
Description
The Dutch institute of Prevention and Health and the Leiden University Hospital (TNO-AZL) preschool quality of life clustered into 12 multi-item scales is used to assess the health-related quality of life, such as children's motor, communication, emotions, and body structure. Suitable for children from 6 months to 6 years old (TAPQOL). Parents fill in according to the child's condition. Higher score (range 0-100) represent better outcome. In this study, the TAPQOL was assessed for children of age 0-3 years.
Time Frame
Week 0, week 52
Title
Health Economic Impact of N9-GP Treatment Through Characterisation of General Hospitalisation
Description
Health economic impact of N9-GP treatment is presented through number of general hospitalization days.
Time Frame
From 0 to 52 weeks
Title
Health Economic Impact of N9-GP Treatment Through Characterisation of Intensive Care Hospitalisation
Description
Health economic impact of N9-GP treatment is presented through number of intensive care hospitalization days.
Time Frame
From 0 to 52 weeks
Title
Health Economic Impact of N9-GP Treatment Through Characterisation of Bleedings Caused Missing School or Studies
Description
Health economic impact of N9-GP treatment through number of days bleedings caused missing school or studies. Number of participants who missed school or studies for 0,1 and 2 days are presented.
Time Frame
From 0 to 52 weeks
Title
Health Economic Impact of N9-GP Treatment Through Characterisation of Number of Days Bleedings Caused Using of Mobility Aids
Description
Health economic impact of N9-GP treatment through number of days the patient used mobility aids (wheelchair and/or crutches) is presented.
Time Frame
From 0 to 52 weeks
Title
Health Economic Impact of N9-GP Treatment Through Characterisation of Number of Days Bleedings Caused Parents to Miss Work
Description
Health economic impact of N9-GP treatment through number of days bleedings caused parents to miss work is presented.
Time Frame
From 0 to 52 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records Age below or equal to 12 years (until patient turns 13 years, at time of inclusion) Body weight above or equal to 10 kg History of at least 50 exposure days (EDs) to other FIX products The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures Exclusion Criteria: Known history of FIX inhibitors Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU) Congenital or acquired coagulation disorder other than haemophilia B Platelet count below 50,000/mcL at screening Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids) Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2978
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108-4619
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6828
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13081-970
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Split
ZIP/Postal Code
21 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Milano
State/Province
MI
ZIP/Postal Code
20124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka
ZIP/Postal Code
420-8660
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
167-0035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordiskdisclosure commitment on novonordisk-trials.com
Citations:
Citation
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)
Results Reference
background
PubMed Identifier
27174727
Citation
Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu MY, Persson P, Rangarajan S, Santagostino E. Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial. J Thromb Haemost. 2016 Aug;14(8):1521-9. doi: 10.1111/jth.13360. Epub 2016 Jun 22.
Results Reference
result
PubMed Identifier
32369845
Citation
Carcao M, Kearney S, Lu MY, Taki M, Rubens D, Shen C, Santagostino E. Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B. Thromb Haemost. 2020 May;120(5):737-746. doi: 10.1055/s-0040-1709521. Epub 2020 May 5.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

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