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Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A (guardian™ 3)

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: NCT01138501
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : June 11, 2014
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: rFVIII Drug: turoctocog alfa
Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

Drug: turoctocog alfa
Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.




Primary Outcome Measures :
  1. The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject. ]
    The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.


Secondary Outcome Measures :
  1. Frequency of Adverse Events (AEs) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject ]
    Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.



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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
  • Age below 12 years and weight at least 11 kg

Exclusion Criteria:

  • Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
  • Congenital or acquired coagulation disorders other than haemophilia A
  • Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)

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): NCT01138501


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
United States, California
Novo Nordisk Investigational Site
Orange, California, United States, 92868
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004
United States, Florida
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Augusta, Georgia, United States, 30912
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201
Novo Nordisk Investigational Site
East Lansing, Michigan, United States, 48823
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64108-4619
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-2168
United States, New York
Novo Nordisk Investigational Site
Brooklyn, New York, United States, 11201-5425
Novo Nordisk Investigational Site
Valhalla, New York, United States, 10595
United States, Ohio
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45404
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239-3098
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76104
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Brazil
Novo Nordisk Investigational Site
Curitiba, Parana, Brazil, 80250-060
Novo Nordisk Investigational Site
Campinas, Sao Paulo, Brazil, 13081970
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 05403-000
Novo Nordisk Investigational Site
Rio de Janeiro, Brazil, 20211-030
Italy
Novo Nordisk Investigational Site
Milano, Italy, 20124
Japan
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan, 4208660
Lithuania
Novo Nordisk Investigational Site
Vilnius, Lithuania, LT-08406
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, 00-576
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-345
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00935
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 105077
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 40447
Turkey
Novo Nordisk Investigational Site
Adana, Turkey, 01130
Novo Nordisk Investigational Site
Antalya, Turkey, 01010
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Izmit, Turkey, 41380
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:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01138501    
Obsolete Identifiers: NCT01250028
Other Study ID Numbers: NN7008-3545
U1111-1113-7182 ( Other Identifier: WHO )
2009-016383-36 ( EudraCT Number )
First Posted: June 7, 2010    Key Record Dates
Results First Posted: June 11, 2014
Last Update Posted: March 17, 2017
Last Verified: February 2017
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
Factor VIII
Coagulants