Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
NCT ID: NCT01138501
Last Updated: 2017-03-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2010-06-30
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
NCT00840086
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
NCT00984126
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
NCT01493778
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
NCT01731600
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
NCT02137850
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rFVIII
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age below 12 years and weight at least 11 kg
Exclusion Criteria
* Congenital or acquired coagulation disorders other than haemophilia A
* Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
11 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Torrance, California, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Augusta, Georgia, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Detroit, Michigan, United States
Novo Nordisk Investigational Site
East Lansing, Michigan, United States
Novo Nordisk Investigational Site
Kansas City, Missouri, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Brooklyn, New York, United States
Novo Nordisk Investigational Site
Valhalla, New York, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Fort Worth, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Curitiba, Paraná, Brazil
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novo Nordisk Investigational Site
Campinas, São Paulo, Brazil
Novo Nordisk Investigational Site
São Paulo, São Paulo, Brazil
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, , Japan
Novo Nordisk Investigational Site
Vilnius, , Lithuania
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Wroclaw, , Poland
Novo Nordisk Investigational Site
San Juan, , Puerto Rico
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Belgrade, , Serbia
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)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kulkarni R, Karim FA, Glamocanin S, Janic D, Vdovin V, Ozelo M, Rageliene L, Carboni E, Laguna P, Dobaczewski G, Seremetis S, Lindblom A, Santagostino E. Results from a large multinational clinical trial (guardian3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013 Sep;19(5):698-705. doi: 10.1111/hae.12165. Epub 2013 May 8.
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 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
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1113-7182
Identifier Type: OTHER
Identifier Source: secondary_id
2009-016383-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN7008-3545
Identifier Type: -
Identifier Source: org_study_id
NCT01250028
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.