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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2012-004867-38-GB
Date of registration: 09/06/2015
Prospective Registration: Yes
Primary sponsor: Novo Nordisk A/S
Public title: Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B
Scientific title: Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a 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 =2%) - paradigm™6
Date of first enrolment: 24/07/2017
Target sample size: 50
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004867-38
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Austria Canada European Union Germany Israel Italy Japan
Malaysia Netherlands Romania Spain Taiwan Thailand United Kingdom United States
Contacts
Name: Global Clinical Registry (GCR,1452)   
Address:  Novo Allé 2880 Bagsværd Denmark
Telephone:
Email: clinicaltrials@novonordisk.com
Affiliation:  Novo Nordisk A/S
Name: Global Clinical Registry (GCR,1452)   
Address:  Novo Allé 2880 Bagsværd Denmark
Telephone:
Email: clinicaltrials@novonordisk.com
Affiliation:  Novo Nordisk A/S
Key inclusion & exclusion 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, < 6 years of age at the time of signing informed consent
- Patients with the diagnosis of haemophilia B (FIX activity level = 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 exposure days to blood components are acceptable)
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 patient’s safety or compliance with the protocol
- Patient’s parent(s)/LAR(s) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Haemophilia B
MedDRA version: 19.0 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX) System Organ Class: 100000004850
Intervention(s)

Product Name: N9-GP 2000IU/vial
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: NONACOG BETA PEGOL
Current Sponsor code: NNC0156-009
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 500-

Product Name: N9-GP 500IU/vial
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: NONACOG BETA PEGOL
Current Sponsor code: NNC0156-009
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Secondary Objective: - To evaluate safety of N9-GP (nonacog beta pegol)
- To evaluate efficacy of N9-GP (nonacog beta pegol)
o in long-term prophylaxis treatment
o in the treatment of bleeding episodes
o through the surrogate marker: FIX activity
o through monitoring of number of doses and consumption of N9-GP
Main Objective: To evaluate immunogenicity of N9-GP (nonacog beta pegol)
Timepoint(s) of evaluation of this end point: All objectives/endpoints will be evaluated 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. End of trial will be up to 4 years after the patient has reached 100 EDs.
Primary end point(s): Incidence of inhibitory antibodies against FIX
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: All objectives/endpoints will be evaluated 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. End of trial will be up to 4 years after the patient has reached 100 EDs.

Secondary end point(s): - Number and frequency of adverse events, serious adverse events, and Medical Events of Special interest
- Number of breakthrough bleeding episodes during prophylaxis (annualised bleeding rate)
- Haemostatic effect by 4-point haemostatic response scale (“excellent”, “good”, “moderate” and “poor”)
Secondary ID(s)
2012-004867-38-DE
NN7999-3895
Source(s) of Monetary Support
Novo Nordisk A/S
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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