Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors (adept™2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392547
First received: July 8, 2011
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: September 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Interventions: Drug: vatreptacog alfa (activated)
Drug: eptacog alfa (activated)

  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
Patients treated with vatreptacog alfa were recruited from a total of 46 sites globally in 18 countries, including Austria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Romania, Russia, Serbia, South Africa, Taiwan, Thailand, Turkey, United Kingdom and United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Subjects All the subjects participating in the trial

Participant Flow:   Overall Study
    All Subjects  
STARTED     72  
COMPLETED     64  
NOT COMPLETED     8  
Adverse Event                 2  
Non-compliance                 2  
Withdrawal criteria                 3  
Unclassified                 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.
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Reporting Groups
  Description
All Subjects All the subjects participating in the trial

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  72  
Age  
[units: years]
Mean ± Standard Deviation
  30.19  ± 13.84  
Gender  
[units: participants]
 
Female     0  
Male     72  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given   [ Time Frame: Within 12 hours of first trial product administration ]

2.  Secondary:   Effective and Sustained Bleeding Control   [ Time Frame: Up to 48 hours after first trial product administration ]

3.  Secondary:   Number of Doses of Trial Product Given for Each Acute Bleed   [ Time Frame: Up to 6 hours after first trial product administration ]

4.  Secondary:   Number of Adverse Events   [ Time Frame: Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product. ]

5.  Secondary:   Immunogenicity   [ Time Frame: Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product. ]


  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


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392547     History of Changes
Other Study ID Numbers: NN1731-3562, 2010-023803-92, U1111-1118-2228, JapicCTI-111595
Study First Received: July 8, 2011
Results First Received: September 27, 2013
Last Updated: June 16, 2014
Health Authority: Austria: Agency for Health and Food Safety
Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Greece: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Taiwan: Department of Health
Thailand: Thai FDA
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration