Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

Completed

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

Key facts

Study ID

NCT02035384

Run by

Novo Nordisk A/S

People needed

69

Starts

2014-06-05

Expected to finish

2020-01-15

Last updated by the study team

2020-04-27

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
• Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
• The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
• A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

You may not qualify if…

• Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
• Treatment with any investigational drug within 30 days prior to enrolment into the study
• Previous participation in any clinical trial with turoctocog alfa
• Treatment with other FVIII products after initiation of treatment with turoctocog alfa

Where it is running

• Novo Nordisk Investigational Site — Mobile, Alabama, United States
• Novo Nordisk Investigational Site — Torrance, California, United States
• Novo Nordisk Investigational Site — Peoria, Illinois, United States
• Novo Nordisk Investigational Site — Albuquerque, New Mexico, United States
• Novo Nordisk Investigational Site — Charlotte, North Carolina, United States
• Novo Nordisk Investigational Site — Salt Lake City, Utah, United States
• Novo Nordisk Investigational Site — Graz, Austria
• Novo Nordisk Investigational Site — Linz, Austria
• Novo Nordisk Investigational Site — Brno, Czechia
• Novo Nordisk Investigational Site — Bordeaux, France
• Novo Nordisk Investigational Site — Montmorency, France
• Novo Nordisk Investigational Site — Rennes, France
• Novo Nordisk Investigational Site — Saint-Etienne, France
• Novo Nordisk Investigational Site — Strasbourg, France
• Novo Nordisk Investigational Site — Braunschweig, Germany
• Novo Nordisk Investigational Site — Duisburg, Germany
• Novo Nordisk Investigational Site — Frankfurt am Main, Germany
• Novo Nordisk Investigational Site — Giessen, Germany
• Novo Nordisk Investigational Site — Leipzig, Germany
• Novo Nordisk Investigational Site — Mörfelden-Walldorf, Germany
• Novo Nordisk Investigational Site — München, Germany
• Novo Nordisk Investigational Site — Münster, Germany
• Novo Nordisk Investigational Site — Athens, Greece
• Novo Nordisk Investigational Site — Budapest, Hungary
• Novo Nordisk Investigational Site — Debrecen, Hungary

Full record on ClinicalTrials.gov

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