Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)
|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|
U.S. FDA Resources
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.
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|