Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)
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|ClinicalTrials.gov Identifier: NCT00840086|
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : September 4, 2014
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Bleeding Disorder Haemophilia A||Drug: turoctocog alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Drug: 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.
- The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject. ]The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
- Frequency of Adverse Events (AEs) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject ]Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
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): NCT00840086
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|