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Trial record 2 of 3 for:    N9-GP

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B (paradigm™6)

This study is currently recruiting participants.
Verified October 2017 by Novo Nordisk A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT02141074
First Posted: May 19, 2014
Last Update Posted: October 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia B Drug: nonacog beta pegol Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of inhibitory antibodies against coagulation factor IX (FIX) [ Time Frame: When the first 20 previously untreated patients (PUPs) have reached at least 50 exposure days (EDs) (Expected to reach between 42 - 60 months) ]
  • Incidence of inhibitory antibodies against coagulation factor IX (FIX) [ Time Frame: When the first 40 PUPs have reached 100 EDs. (Expected to reach within 100 months) ]
  • Incidence of inhibitory antibodies against coagulation factor IX (FIX) [ Time Frame: Expected to reach within 100 months ]

Secondary Outcome Measures:
  • Number and frequency of adverse events [ Time Frame: When the first 20 PUPs have reached at least 50 EDs, when the first 40 PUPs have reached 100 EDs, and at end of trial (Expected to reach between 42 - 100 months) ]
  • Number and frequency of serious adverse events [ Time Frame: When the first 20 PUPs have reached at least 50 EDs, when the first 40 PUPs have reached 100 EDs, and at end of trial (Expected to reach between 42 - 100 months) ]
  • Number and frequency of Medical Events of Special Interest [ Time Frame: When the first 20 PUPs have reached at least 50 EDs, when the first 40 PUPs have reached 100 EDs, and at end of trial (Expected to reach between 42 - 100 months) ]
  • Number of breakthrough bleeding episodes during prophylaxis (annualised bleeding rate) Haemostatic effect by 4-point haemostatic response scale ("excellent", "good", "moderate" and "poor") [ Time Frame: When the first 20 PUPs have reached at least 50 EDs, when the first 40 PUPs have reached 100 EDs, and at end of trial (Expected to reach between 42 - 100 months) ]
  • Haemostatic effect by 4-point haemostatic response scale ("excellent", "good", "moderate" and "poor") [ Time Frame: When the first 20 PUPs have reached at least 50 EDs, when the first 40 PUPs have reached 100 EDs, and at end of trial (Expected to reach between 42 - 100 months) ]

Estimated Enrollment: 50
Actual Study Start Date: July 2, 2014
Estimated Study Completion Date: October 30, 2022
Estimated Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 EDs (exposure days) Drug: nonacog beta pegol
For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male, age below 6 years at the time of signing informed consent
  • Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity level below or equal to 2%) based on medical records or central laboratory results
  • Previously untreated or exposed to FIX containing products less than or equal to 3 exposure days (5 previous exposures to blood components is acceptable)

Exclusion Criteria:

  • Any history of FIX inhibitors (defined by medical records)
  • Known or suspected hypersensitivity to trial product or related products
  • Previous participation in this trial. Participation is defined as first dose administered of trial product
  • Receipt of any investigational medicinal product within 30 days before screening
  • Congenital or acquired coagulation disorder other than haemophilia B
  • Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
  • Patient's parent(s)/LAR(s) (legally acceptable representative) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141074


Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 62 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02141074     History of Changes
Other Study ID Numbers: NN7999-3895
2012-004867-38 ( EudraCT Number )
U1111-1135-9557 ( Other Identifier: WHO )
JapicCTI-142611 ( Registry Identifier: JAPIC )
NL53683.091.15 ( Other Identifier: CCMO )
First Submitted: March 28, 2014
First Posted: May 19, 2014
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Hemorrhage
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases