Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
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|ClinicalTrials.gov Identifier: NCT00108758|
Recruitment Status : Completed
First Posted : April 19, 2005
Last Update Posted : January 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors||Drug: activated recombinant human factor VII||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
- Reduction of bleeds [ Time Frame: During 3 months treatment period as compared to 3 months observation period ]
- Efficacy variables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108758
Show 37 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|