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Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984126
First Posted: September 25, 2009
Last Update Posted: July 27, 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, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) [ Time Frame: After 90 months ]
    The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.


Secondary Outcome Measures:
  • Frequency of Adverse Events and Serious Adverse Events [ Time Frame: After 90 months ]
    The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).

  • Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen) [ Time Frame: After 90 months ]
    The number of bleeding episodes per year reported during the prevention period (during 90 months).

  • Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds. [ Time Frame: After 90 months ]
    Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).


Enrollment: 214
Actual Study Start Date: October 26, 2009
Study Completion Date: June 29, 2016
Primary Completion Date: June 28, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turoctocog alfa Drug: turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
Drug: turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent obtained before any trial-related activities
  • Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion Criteria:

  • Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
  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): NCT00984126


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
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
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, 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, Rhode Island
Novo Nordisk Investigational Site
Providence, Rhode Island, United States, 02903
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37232-9830
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99204
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
Croatia
Novo Nordisk Investigational Site
Split, Croatia, 21 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
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
Israel
Novo Nordisk Investigational Site
Tel Aviv, 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
Kashihara-shi, Nara, Japan, 634 8522
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
Latvia
Novo Nordisk Investigational Site
Riga, Latvia, 1006
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, 50-556
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00935
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119049
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:
Ozelo M, Misgav M, Abdul-Karim F, Lentz S, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Stabilization of turoctocog alfa dose administered in a preventive regimen: 3-year interim results of the guardianTM-2 extension trial. Haemophilia - Special Issue: Abstracts of the WFH 2014 World Congress, May 11-15, Melbourne, Australia; 20 (3): 1-200
Recht M, Lentz S, Zupancic-Salek S, Matytsina I, Landorph A, Saugstrup T. Factor VIII Dosing and Preventive Efficacy in Obese Patients with Hemophilia (BMI =30 kg/m2) - a Post-Hoc Sub-Analysis of the guardian™ Trials. American Society of Hematology - 56th Annual Meeting (ASH); Country: US City: San Francisco, CA

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00984126     History of Changes
Other Study ID Numbers: NN7008-3568
2008-005945-46 ( EudraCT Number )
U1111-1111-9377 ( Other Identifier: WHO )
JapicCTI-101357 ( Registry Identifier: JAPIC )
First Submitted: September 21, 2009
First Posted: September 25, 2009
Results First Submitted: June 27, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 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