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Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00840086
First received: February 6, 2009
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: November 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Congenital Bleeding Disorder
Haemophilia A
Intervention: Drug: turoctocog alfa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients were recruited at 48 sites in 15 countries: Republic of Serbia (5), Turkey (5), Germany (4), Japan (8), the United Kingdom (3) and the United States of America (10). Two sites each in Brazil, Italy, Spain and Croatia. One site each in Switzerland, Taiwan, Israel, Malaysia and Russian Federation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects Treated With Turoctocog Alfa All subjects participating in the study (Part A + Part B + Part C).

Participant Flow:   Overall Study
    All Subjects Treated With Turoctocog Alfa  
STARTED     150  
COMPLETED     146  
NOT COMPLETED     4  
Adverse Event                 1  
Protocol Violation                 2  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Subjects Treated With Turoctocog Alfa All subjects participating in the study (Part A + Part B + Part C).

Baseline Measures
    All Subjects Treated With Turoctocog Alfa  
Number of Participants  
[units: participants]
  150  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 11.79  
Gender  
[units: participants]
 
Female     0  
Male     150  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic Or Latino     25  
Not Hispanic Or Latino     125  
Region of Enrollment  
[units: participants]
 
Brazil     16  
Croatia     11  
Germany     10  
Israel     12  
Italy     7  
Japan     9  
Malaysia     5  
Russia     5  
Serbia     19  
Spain     4  
Switzerland     5  
Taiwan     4  
Turkey     11  
United Kingdom     3  
United States     29  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Frequency of Adverse Events (AEs)   [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided by Novo Nordisk A/S

Publications automatically indexed to this study:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00840086     History of Changes
Other Study ID Numbers: NN7008-3543, 2008-003960-20, 101151
Study First Received: February 6, 2009
Results First Received: November 14, 2013
Last Updated: September 3, 2014
Health Authority: Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and medical devices agency (PMDA)
Malaysia: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Agency of Medicines and Health Care Products
Switzerland: Swissmedic
Taiwan: Department of Health, Executive Yuan, R.O.C.
Turkey: Ministry of Health Drug and Pharmaceutical Department
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration