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Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

NCT01467427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-23

Study results available
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Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia B

Interventions

DRUG

nonacog beta pegol

A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-05-16
Primary Completion
2023-11-17
Completion
2023-11-17
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Croatia
  • France
  • Germany
  • Italy
  • Japan
  • Malaysia
  • Taiwan
  • Turkey (Türkiye)
  • 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 NCT01467427 on ClinicalTrials.gov