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Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A | Clinical Trials | Clareo Health

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

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

NCT01493778•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 6 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Age below 6 years
•Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
•Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
•No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®

Exclusion Criteria

•Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
•Previous participation in this trial defined as withdrawal after administration of trial product
•Congenital or acquired coagulation disorders other than haemophilia A
•Any history of Factor VIII inhibitor
•Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)

Locations (69)

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Long Beach, California, United States

Novo Nordisk Investigational Site

Sacramento, California, United States

Novo Nordisk Investigational Site

Washington D.C., District of Columbia, United States

Novo Nordisk Investigational Site

Gainesville, Florida, United States

Novo Nordisk Investigational Site

Orlando, Florida, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Augusta, Georgia, United States

Novo Nordisk Investigational Site

Macon, Georgia, United States

Key Dates

Start Date

September 17, 2012

Primary Completion Date

August 16, 2017

Completion Date

December 5, 2018

Last Updated

November 30, 2020

Enrollment

60

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia A

Interventions

turoctocog alfa

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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