Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
163 participants
OBSERVATIONAL
2005-10-31
2012-01-31
Brief Summary
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Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FVII
activated recombinant human factor VII
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Fresh frozen plasma (Source unspecified)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII (LFB)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Prothrombin Complex conc. (PCC)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII conc. (pdFVII Baxter)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII conc. (pdFVII PFL)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Interventions
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activated recombinant human factor VII
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Fresh frozen plasma (Source unspecified)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII (LFB)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Prothrombin Complex conc. (PCC)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII conc. (pdFVII Baxter)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Plasma-derived FVII conc. (pdFVII PFL)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Eligibility Criteria
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Inclusion Criteria
* Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is considered necessary by the treating physician can be enrolled
* Patients with FVII deficiency without any immediate need for treatment will be entered as stand by registered patients with capture of baseline- and demographic data only. Admission data is entered once an event occurs
ALL
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
Princeton, New Jersey, United States
Novo Nordisk Investigational Site
Paris La Défense Cedex, , France
Novo Nordisk Investigational Site
Mainz, , Germany
Novo Nordisk Investigational Site
Vouliagment, , Greece
Novo Nordisk Investigational Site
Kowloon, , Hong Kong
Novo Nordisk Investigational Site
Bangalore, , India
Novo Nordisk Investigational Site
Tehran, , Iran
Novo Nordisk Investigational Site
Kfar Saba, , Israel
Novo Nordisk Investigational Site
Rome, , Italy
Novo Nordisk Investigational Site
Karachi, , Pakistan
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Caracas, , Venezuela
Countries
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References
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Mariani G, Dolce A, Batorova A, Auerswald G, Schved JF, Siragusa S, Napolitano M, Knudsen JB, Ingerslev J; STER and the International Factor VII Deficiency Study Groups. Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER. Br J Haematol. 2011 Feb;152(3):340-6. doi: 10.1111/j.1365-2141.2010.08287.x. Epub 2010 Dec 16.
Mariani G, Dolce A, Napolitano M, Ingerslev J, Giansily-Blaizot M, Di Minno MD, Auerswald G, De Saez AR, Tagliaferri A, Batorova A; STER (Seven Treatment Evaluation Registry). Invasive procedures and minor surgery in factor VII deficiency. Haemophilia. 2012 May;18(3):e63-5. doi: 10.1111/j.1365-2516.2012.02751.x. Epub 2012 Feb 22. No abstract available.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7HAEM-3578
Identifier Type: -
Identifier Source: org_study_id
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