Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
NCT ID: NCT00840086
Last Updated: 2017-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2009-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rFVIII
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* Creatinine levels 50% above normal level (as defined by central laboratory range)
* Known or suspected allergy to trial product (N8) or related products
12 Years
65 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Augusta, Georgia, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Newark, New Jersey, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Providence, Rhode Island, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Novo Nordisk Investigational Site
Nashville, Tennessee, United States
Novo Nordisk Investigational Site
Fort Worth, Texas, United States
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novo Nordisk Investigational Site
Split, , Croatia
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Bonn, , Germany
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Giessen, , Germany
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Hanover, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
Novo Nordisk Investigational Site
Tel Litwinsky, , Israel
Novo Nordisk Investigational Site
Florence, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, , Japan
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, , Japan
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, , Japan
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, , Japan
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Belgrade, , Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, , Serbia and Montenegro
Novo Nordisk Investigational Site
Nis, , Serbia and Montenegro
Novo Nordisk Investigational Site
Novi Sad, , Serbia and Montenegro
Novo Nordisk Investigational Site
Novi Sad, , Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Niš, , Serbia
Novo Nordisk Investigational Site
Novi Sad, , Serbia
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Adana, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Bornova-IZMIR, , Turkey (Türkiye)
Novo Nordisk Investigational Site
İzmit, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Samsun, , Turkey (Türkiye)
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Countries
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References
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Lentz SR, Misgav M, Ozelo M, Salek SZ, Veljkovic D, Recht M, Cerqueira M, Tiede A, Brand B, Mancuso ME, Seremetis S, Lindblom A, Martinowitz U. Results from a large multinational clinical trial (guardian1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013 Sep;19(5):691-7. doi: 10.1111/hae.12159. Epub 2013 May 7.
Santagostino E, Lentz SR, Misgav M, Brand B, Chowdary P, Savic A, Kilinc Y, Amit Y, Amendola A, Solimeno LP, Saugstrup T, Matytsina I. Safety and efficacy of turoctocog alfa (NovoEight(R)) during surgery in patients with haemophilia A: results from the multinational guardian clinical trials. Haemophilia. 2015 Jan;21(1):34-40. doi: 10.1111/hae.12518. Epub 2014 Oct 2.
Ozelo M, Chowdary P, Regnault A, Busk AK. Impact of severe haemophilia A on patients' health status: results from the guardian() 1 clinical trial of turoctocog alfa (NovoEight((R)) ). Haemophilia. 2015 Jul;21(4):451-7. doi: 10.1111/hae.12617. Epub 2015 Feb 12.
Ozelo MC. Updates from guardian: a comprehensive registration programme. Eur J Haematol. 2015 Dec;95 Suppl 81:22-9. doi: 10.1111/ejh.12648.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-003960-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
101151
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7008-3543
Identifier Type: -
Identifier Source: org_study_id
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