Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004867-38-GB

Enrollment

Registered

2015-06-09

Start date

2017-07-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia B MedDRA version: 19.0 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX) System Organ Class: 100000004850

Interventions

Product Name: N9-GP 2000IU/vial Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: NONACOG BETA PEGOL Current Spons

Eligibility

Sex/Gender

Male

Inclusion 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, =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate immunogenicity of N9-GP (nonacog beta pegol); 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 ;Primary end point(s): Incidence of inhibitory antibodies against FIX;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.	—

Measure

Time frame

Main Objective: To evaluate immunogenicity of N9-GP (nonacog beta pegol); 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 ;Primary end point(s): Incidence of inhibitory antibodies against FIX;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.

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Secondary

Measure	Time frame
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”) ;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.	—

Measure

Time frame

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”) ;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.

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Countries

Australia, Austria, Canada, European Union, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Romania, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026