Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01125813
First received: May 17, 2010
Last updated: March 11, 2013
Last verified: March 2013
Results First Received: January 21, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Severe Hemophilia A
Intervention: Biological: recombinant Factor VIII

  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
Participants were enrolled at 11 European sites beginning June 2010 and completing in January 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
36 participants were enrolled and screened. 4 were screen failures. Therefore, 32 of the 36 enrolled were exposed to investigation product.

Reporting Groups
  Description
Human Cl-rhFVIII recombinant Factor VIII : intravenous infusion of factor FVIII every other day.

Participant Flow:   Overall Study
    Human Cl-rhFVIII  
STARTED     36  
COMPLETED     30  
NOT COMPLETED     6  
Death                 1  
Withdrawal by Subject                 1  
Screen Failures                 4  



  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
Human Cl-rhFVIII recombinant Factor VIII : intravenous infusion of factor FVIII every other day.

Baseline Measures
    Human Cl-rhFVIII  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  37.3  ± 13.6  
Gender  
[units: participants]
 
Female     0  
Male     32  
Region of Enrollment  
[units: participants]
 
Austria     1  
Bulgaria     8  
Germany     8  
United Kingdom     15  



  Outcome Measures
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1.  Primary:   Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months   [ Time Frame: At least 50 Exposure Days and at least 6 months ]

2.  Primary:   Efficacy of Treating Bleeding Episodes   [ Time Frame: After each bleeding episode, up to 6 month ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Sigurd Knaub
Organization: Octapharma AG
phone: 41 55 451 21 41
e-mail: sigurd.knaub@octapharma.ch


No publications provided


Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01125813     History of Changes
Other Study ID Numbers: GENA-08
Study First Received: May 17, 2010
Results First Received: January 21, 2013
Last Updated: March 11, 2013
Health Authority: Germany: Paul Ehrlich Institute
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: AGES
Bulgaria: Bulgarian Drug Agency