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
June 27, 2017 updated by: Novo Nordisk A/S
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 20211-030
- Novo Nordisk Investigational Site
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Parana
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Curitiba, Parana, Brazil, 80250-060
- Novo Nordisk Investigational Site
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Sao Paulo
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Campinas, Sao Paulo, Brazil, 13081970
- Novo Nordisk Investigational Site
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São Paulo, Sao Paulo, Brazil, 05403-000
- Novo Nordisk Investigational Site
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Split, Croatia, 21 000
- Novo Nordisk Investigational Site
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Zagreb, Croatia, 10 000
- Novo Nordisk Investigational Site
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Berlin, Germany, 10249
- Novo Nordisk Investigational Site
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Bonn, Germany, 53127
- Novo Nordisk Investigational Site
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Giessen, Germany, 35392
- Novo Nordisk Investigational Site
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Hannover, Germany, 30625
- Novo Nordisk Investigational Site
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Tel Aviv, Israel
- Novo Nordisk Investigational Site
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Tel-Hashomer, Israel, 52621
- Novo Nordisk Investigational Site
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Firenze, Italy, 50134
- Novo Nordisk Investigational Site
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Milano, Italy, 20124
- Novo Nordisk Investigational Site
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Kashihara-shi, Nara, Japan, 634 8522
- Novo Nordisk Investigational Site
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Nagoya-shi, Aichi, Japan, 466 8560
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japan, 329 0498
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, Japan, 160 0023
- Novo Nordisk Investigational Site
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Shizuoka-shi, Shizuoka, Japan, 4208660
- Novo Nordisk Investigational Site
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Riga, Latvia, 1006
- Novo Nordisk Investigational Site
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Vilnius, Lithuania, LT-08406
- Novo Nordisk Investigational Site
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Skopje, Macedonia, The Former Yugoslav Republic of, 1000
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 50400
- Novo Nordisk Investigational Site
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Warszawa, Poland, 00-576
- Novo Nordisk Investigational Site
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Wroclaw, Poland, 50-556
- Novo Nordisk Investigational Site
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San Juan, Puerto Rico, 00935
- Novo Nordisk Investigational Site
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Moscow, Russian Federation, 119049
- Novo Nordisk Investigational Site
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Saint-Petersburg, Russian Federation, 191119
- Novo Nordisk Investigational Site
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Belgrade, Serbia, 11000
- Novo Nordisk Investigational Site
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Belgrade, Serbia, 11070
- Novo Nordisk Investigational Site
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Nis, Serbia, 18000
- Novo Nordisk Investigational Site
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Novi Sad, Serbia, 21000
- Novo Nordisk Investigational Site
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Madrid, Spain, 28046
- Novo Nordisk Investigational Site
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Valencia, Spain, 46026
- Novo Nordisk Investigational Site
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Zürich, Switzerland, 8091
- Novo Nordisk Investigational Site
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Taipei, Taiwan, 100
- Novo Nordisk Investigational Site
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Adana, Turkey, 01130
- Novo Nordisk Investigational Site
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Antalya, Turkey, 01010
- Novo Nordisk Investigational Site
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Bornova-IZMIR, Turkey, 35100
- Novo Nordisk Investigational Site
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Izmit, Turkey, 41380
- Novo Nordisk Investigational Site
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Samsun, Turkey, 55319
- Novo Nordisk Investigational Site
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London, United Kingdom, NW3 2QG
- Novo Nordisk Investigational Site
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London, United Kingdom, SE1 7EH
- Novo Nordisk Investigational Site
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Manchester, United Kingdom, M13 9WL
- Novo Nordisk Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85016-7710
- Novo Nordisk Investigational Site
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California
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Long Beach, California, United States, 90806
- Novo Nordisk Investigational Site
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Florida
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Tampa, Florida, United States, 33607
- Novo Nordisk Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Novo Nordisk Investigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- Novo Nordisk Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Novo Nordisk Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45229
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45404
- Novo Nordisk Investigational Site
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Oregon
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Portland, Oregon, United States, 97239
- Novo Nordisk Investigational Site
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Novo Nordisk Investigational Site
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Tennessee
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Nashville, Tennessee, United States, 37232-9830
- Novo Nordisk Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Novo Nordisk Investigational Site
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Washington
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Spokane, Washington, United States, 99204
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Turoctocog alfa
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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.
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g.
before physical activity)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)
Time Frame: After 90 months
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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.
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After 90 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Frequency of Adverse Events and Serious Adverse Events
Time Frame: After 90 months
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The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).
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After 90 months
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Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)
Time Frame: After 90 months
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The number of bleeding episodes per year reported during the prevention period (during 90 months).
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After 90 months
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Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.
Time Frame: After 90 months
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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).
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After 90 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
- Ozelo M, Misgav M, Abdul Karim F, Lentz SR, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight((R)) ) in previously treated patients with severe haemophilia A: interim results of the guardian() 2 extension trial. Haemophilia. 2015 Sep;21(5):e436-9. doi: 10.1111/hae.12737. Epub 2015 Jun 8. No abstract available.
- Lentz SR, Cerqueira M, Janic D, Kempton C, Matytsina I, Misgav M, Oldenburg J, Ozelo M, Recht M, Rosholm A, Savic A, Suzuki T, Tiede A, Santagostino E. Interim results from a large multinational extension trial (guardian() 2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016 Sep;22(5):e445-9. doi: 10.1111/hae.12990. Epub 2016 Jun 13. No abstract available.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2009
Primary Completion (Actual)
June 28, 2016
Study Completion (Actual)
June 29, 2016
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (Estimate)
September 25, 2009
Study Record Updates
Last Update Posted (Actual)
July 27, 2017
Last Update Submitted That Met QC Criteria
June 27, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN7008-3568
- 2008-005945-46 (EudraCT Number)
- U1111-1111-9377 (Other Identifier: WHO)
- JapicCTI-101357 (Registry Identifier: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.