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Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840086
First Posted: February 10, 2009
Last Update Posted: March 17, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa Phase 3

Study Type: Interventional
Study Design: 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 Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 188 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:
  • Frequency of Adverse Events (AEs) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 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 AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.


Enrollment: 150
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIII Drug: turoctocog alfa
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
  • Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
  • No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
  • No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

  • Congenital or acquired coagulation disorders other than haemophilia A
  • Creatinine levels 50% above normal level (as defined by central laboratory range)
  • Known or suspected allergy to trial product (N8) or related products
  Contacts and Locations
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): NCT00840086


  Hide Study Locations
Locations
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
United States, Florida
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
Novo Nordisk Investigational Site
Augusta, Georgia, United States, 30912
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-2168
United States, New Jersey
Novo Nordisk Investigational Site
Newark, New Jersey, United States, 07102
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45404
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Novo Nordisk Investigational Site
Providence, Rhode Island, United States, 02903
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38163
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37232-9830
United States, Texas
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76104
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99204
Brazil
Novo Nordisk Investigational Site
Rio de Janeiro, Brazil, 20211-030
Croatia
Novo Nordisk Investigational Site
Split, Croatia, 21 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Denmark
Novo Nordisk Investigational Site
København, Denmark, 2100
Former Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, Former Serbia and Montenegro, 11000
Novo Nordisk Investigational Site
Belgrade, Former Serbia and Montenegro, 11070
Novo Nordisk Investigational Site
Nis, Former Serbia and Montenegro, 18000
Novo Nordisk Investigational Site
Novi Sad, Former Serbia and Montenegro, 21 000
Novo Nordisk Investigational Site
Novi Sad, Former Serbia and Montenegro, 21000
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Giessen, Germany, 35392
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Debrecen, Hungary, 4012
Israel
Novo Nordisk Investigational Site
Tel-Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Japan
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, Japan, 734 8551
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan, 173 8606
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, Japan, 371-8511
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329 0498
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan, 4208660
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 1670035
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Russian Federation
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Nis, Serbia, 18000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
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
Novo Nordisk Investigational Site
Samsun, Turkey, 55319
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00840086     History of Changes
Other Study ID Numbers: NN7008-3543
2008-003960-20 ( EudraCT Number )
101151 ( Registry Identifier: JAPIC )
First Submitted: February 6, 2009
First Posted: February 10, 2009
Results First Submitted: November 14, 2013
Results First Posted: September 4, 2014
Last Update Posted: March 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hemorrhage
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants