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Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (guardian™ 5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035384
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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).

Condition or disease Intervention/treatment
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)
Actual Study Start Date : June 5, 2014
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Group/Cohort Intervention/treatment
All patients Drug: 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.




Primary Outcome Measures :
  1. Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors [ Time Frame: Within approximately 7 years ]

Secondary Outcome Measures :
  1. Number of adverse reactions reported [ Time Frame: During approximately 7 years ]
  2. Number of serious adverse reactions reported [ Time Frame: During approximately 7 years ]
  3. Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
  4. Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
  5. Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [ Time Frame: Within approximately 7 years ]
  6. Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [ Time Frame: Within approximately 7 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035384


Locations
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United States, Alabama
Novo Nordisk Investigational Site
Mobile, Alabama, United States, 36604
United States, California
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004
United States, Illinois
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61615
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84113
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Linz, Austria, 4020
Czechia
Novo Nordisk Investigational Site
Brno, Czechia, 625 00
France
Novo Nordisk Investigational Site
Bordeaux, France, 33076
Novo Nordisk Investigational Site
Montmorency, France, 95160
Novo Nordisk Investigational Site
Rennes, France, 35033
Novo Nordisk Investigational Site
Saint Etienne, France, 42055
Novo Nordisk Investigational Site
Strasbourg, France, 67098
Germany
Novo Nordisk Investigational Site
Braunschweig, Germany, 38118
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Novo Nordisk Investigational Site
Frankfurt / Main, Germany, 60596
Novo Nordisk Investigational Site
Giessen, Germany, 35392
Novo Nordisk Investigational Site
Leipzig, Germany, 04289
Novo Nordisk Investigational Site
Mörfelden-Walldorf, Germany, 64546
Novo Nordisk Investigational Site
München, Germany, 80331
Novo Nordisk Investigational Site
Münster, Germany, 48143
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Debrecen, Hungary, 4032
Novo Nordisk Investigational Site
Mohács, Hungary, 7700
Italy
Novo Nordisk Investigational Site
Castelfranco Veneto, Italy, 31033
Novo Nordisk Investigational Site
Catania, Italy, 95123
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Padova, Italy, 35128
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Netherlands
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2545AA
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3584 CX
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, 02-091
Slovakia
Novo Nordisk Investigational Site
Banska Bystrica, Slovakia, 975 17
Novo Nordisk Investigational Site
Kosice, Slovakia, 04001
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1000
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02035384    
Other Study ID Numbers: NN7008-3553
U1111-1126-0353 ( Other Identifier: WHO )
ENCEPP/SDPP/5501 ( Registry Identifier: EU PAS )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases