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Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

NCT01333111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-07-28

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia B

Interventions

DRUG

nonacog beta pegol

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

DRUG

nonacog beta pegol

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

DRUG

nonacog beta pegol

Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-27
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • North Macedonia
  • Russia
  • South Africa
  • 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 NCT01333111 on ClinicalTrials.gov