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

NCT02141074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-23

Study results available
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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.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia B

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-02
Primary Completion
2022-10-27
Completion
2022-10-27

Countries

  • United States
  • Algeria
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Portugal
  • Romania
  • Serbia
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141074 on ClinicalTrials.gov