Main
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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:
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EUCTR |
Last refreshed on:
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4 September 2023 |
Main ID: |
EUCTR2012-004867-38-AT |
Date of registration:
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09/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B
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Scientific title:
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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:
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22/06/2015 |
Target sample size:
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60 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004867-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Canada
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European Union
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Germany
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Israel
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Italy
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Japan
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Malaysia
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Netherlands
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Romania
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Spain
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Taiwan
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Disclosure (1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Clinical Disclosure (1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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: 60 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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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Haemophilia B MedDRA version: 20.0
Level: LLT
Classification code 10018939
Term: Haemophilia B (Factor IX)
System Organ Class: 100000004850
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Intervention(s)
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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-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: All objectives/endpoints will be evaluated when minimum 20 PUPs have reached at least 50 exposure days (EDs), when minimum 40 PUPs have reached at least 100 EDs, and at end of trial.
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Primary end point(s): Incidence of inhibitory antibodies against FIX
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Main Objective: To evaluate immunogenicity of N9-GP (nonacog beta pegol)
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Secondary Objective: - To evaluate safety of N9-GP (nonacog beta pegol) - To evaluate efficacy of N9-GP (nonacog beta pegol) - in long-term prophylaxis treatment - in the treatment of bleeding episodes - through the surrogate marker: FIX activity - through monitoring of number of doses and consumption of N9-GP
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: All objectives/endpoints will be evaluated when minimum 20 PUPs have reached at least 50 exposure days (EDs), when minimum 40 PUPs have reached at least 100 EDs, and at end of trial.
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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”)
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Secondary ID(s)
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NN7999-3895
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2012-004867-38-DE
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Ethics review
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Status: Approved
Approval date: 11/04/2014
Contact:
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