Congenital Bleeding Disorder Clinical Trial
Official title:
Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe, South America, and the United States of
America (USA).
The purpose of this study is to evaluate the effectiveness of secondary prophylactic
treatment with NovoSeven® in haemophilia A and B patients with inhibitors.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively Exclusion Criteria: - Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Ciudad Autónoma de Bs. As. | |
| Brazil | Novo Nordisk Investigational Site | Belo Horizonte | |
| Brazil | Novo Nordisk Investigational Site | Campinas | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Recife | |
| Brazil | Novo Nordisk Investigational Site | Ribeirao Preto | |
| Brazil | Novo Nordisk Investigational Site | Rio de Janeiro | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| France | Novo Nordisk Investigational Site | Kremlin-Bicêtre | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | Paris | |
| Philippines | Novo Nordisk Investigational Site | Manila | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Romania | Novo Nordisk Investigational Site | Bucharest | |
| Romania | Novo Nordisk Investigational Site | Timisoara | Timis |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Santander | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Turkey | Novo Nordisk Investigational Site | Bornova-IZMIR | |
| Turkey | Novo Nordisk Investigational Site | Capa-ISTANBUL | |
| United States | Novo Nordisk Investigational Site | Berkeley | California |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Iowa City | Iowa |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | New Hyde Park | New York |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | Newark | New Jersey |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Argentina, Brazil, Bulgaria, France, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Turkey,
Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of bleeds | During 3 months treatment period as compared to 3 months observation period | No | |
| Secondary | Efficacy variables | No |
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