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Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

NCT01480180 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-11-23

Study results available
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Summary

This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A

Interventions

DRUG

turoctocog alfa pegol

Administered i.v.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-30
Primary Completion
2018-12-10
Completion
2018-12-10

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Croatia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Norway
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT01480180 on ClinicalTrials.gov