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Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

NCT01386528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-08-23

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia B

Interventions

DRUG

nonacog beta pegol

The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-07
Primary Completion
2013-12-01
Completion
2013-12-01

Countries

  • United States
  • Austria
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • North Macedonia
  • Romania
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • 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 NCT01386528 on ClinicalTrials.gov