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

NCT ID: NCT02035384

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-05

Study Completion Date

2020-01-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

turoctocog alfa

Intervention Type DRUG

Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.

Interventions

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turoctocog alfa

Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mobile, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Torrance, California, United States

Site Status

Novo Nordisk Investigational Site

Peoria, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Albuquerque, New Mexico, United States

Site Status

Novo Nordisk Investigational Site

Charlotte, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Salt Lake City, Utah, United States

Site Status

Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Linz, , Austria

Site Status

Novo Nordisk Investigational Site

Brno, , Czechia

Site Status

Novo Nordisk Investigational Site

Bordeaux, , France

Site Status

Novo Nordisk Investigational Site

Montmorency, , France

Site Status

Novo Nordisk Investigational Site

Rennes, , France

Site Status

Novo Nordisk Investigational Site

Saint-Etienne, , France

Site Status

Novo Nordisk Investigational Site

Strasbourg, , France

Site Status

Novo Nordisk Investigational Site

Braunschweig, , Germany

Site Status

Novo Nordisk Investigational Site

Duisburg, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt am Main, , Germany

Site Status

Novo Nordisk Investigational Site

Giessen, , Germany

Site Status

Novo Nordisk Investigational Site

Leipzig, , Germany

Site Status

Novo Nordisk Investigational Site

Mörfelden-Walldorf, , Germany

Site Status

Novo Nordisk Investigational Site

München, , Germany

Site Status

Novo Nordisk Investigational Site

Münster, , Germany

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Debrecen, , Hungary

Site Status

Novo Nordisk Investigational Site

Mohács, , Hungary

Site Status

Novo Nordisk Investigational Site

Castelfranco Veneto, , Italy

Site Status

Novo Nordisk Investigational Site

Catania, , Italy

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Padua, , Italy

Site Status

Novo Nordisk Investigational Site

Palermo, , Italy

Site Status

Novo Nordisk Investigational Site

The Hague, , Netherlands

Site Status

Novo Nordisk Investigational Site

Utrecht, , Netherlands

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Banská Bystrica, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Ljubljana, , Slovenia

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Countries

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United States Austria Czechia France Germany Greece Hungary Italy Netherlands Poland Slovakia Slovenia Spain Sweden Switzerland

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1126-0353

Identifier Type: OTHER

Identifier Source: secondary_id

ENCEPP/SDPP/5501

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN7008-3553

Identifier Type: -

Identifier Source: org_study_id

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