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Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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 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)

NCT02141074•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 6 years

Sex

MALE

Healthy Volunteers

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

Locations (93)

Miller Children's Hospital Long Beach

Long Beach, California, United States

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Augusta University

Augusta, Georgia, United States

Hope for Kids

Macon, Georgia, United States

St. Luke's Mountain States Tumor Institute

Boise, Idaho, United States

University Of Iowa

Iowa City, Iowa, United States

Children's Hosp-New Orleans

New Orleans, Louisiana, United States

Johns Hopkins University_Baltimore_3

Baltimore, Maryland, United States

Key Dates

Start Date

July 2, 2014

Primary Completion Date

October 27, 2022

Completion Date

October 27, 2022

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia B

Interventions

nonacog beta pegol

DRUG

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

NCT06285071

Haemophilia AHaemophilia B

View study

ENROLLING_BY_INVITATION

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Haemophilia A, Haemophilia B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

Dosage and PD Study of Eftrenonacog-alfa

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

ATHN 7: Hemophilia Natural History Study

Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B