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Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

NCT01493778 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-30

Study results available
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Summary

This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A

Interventions

DRUG

turoctocog alfa

Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.

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
2012-09-17
Primary Completion
2017-08-16
Completion
2018-12-05
FDA Drug
Yes

Countries

  • United States
  • Algeria
  • Austria
  • Brazil
  • China
  • Denmark
  • Greece
  • Hong Kong
  • Hungary
  • Japan
  • Lithuania
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

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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 NCT01493778 on ClinicalTrials.gov