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Study Evaluating Refacto For Pharmacovigilance

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ClinicalTrials.gov Identifier: NCT00195442
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : February 7, 2011
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hemophilia A
Intervention: Drug: Moroctocog alfa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 288 participants were observed during the study in 48 centers (44 Germany and 4 Austria) from time of First subject first visit May 1999 to Last subject last visit January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was terminated January 2010 due to the introduction of a successor product ReFacto® AF.

Reporting Groups
  Description
ReFacto (Moroctocog Alfa) B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.

Participant Flow:   Overall Study
    ReFacto (Moroctocog Alfa)
STARTED   288 
COMPLETED   152 
NOT COMPLETED   136 
Less than expected therapeutic effect                38 
Lost to Follow-up                27 
Switch to other Factor VIII preparation                23 
Intermittent product shortage                21 
Death                7 
No reason specified                4 
Poor cooperation                2 
Other                14 



  Baseline Characteristics

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
ReFacto (Moroctocog Alfa) B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.

Baseline Measures
   ReFacto (Moroctocog Alfa) 
Overall Participants Analyzed 
[Units: Participants]
 288 
Age, Customized 
[Units: Participants]
 
Children < 18 years of age   106 
Adults ≥ 18 years of age   182 
Gender 
[Units: Participants]
 
Female   0 
Male   288 


  Outcome Measures

1.  Primary:   Mean Number of Bleeding Episodes Per Patient Year   [ Time Frame: Baseline up to a mean duration of 54 months ]

2.  Primary:   Mean Number of Bleeding-related Exposure Days Per Patient Year   [ Time Frame: Baseline up to a mean duration of 54 months ]

3.  Primary:   Mean Number of Exposure Days Per Patient Year   [ Time Frame: Baseline up to a mean duration of 54 months ]

4.  Secondary:   Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to a mean duration of 54 months ]

5.  Secondary:   Number of Participants With de Novo Inhibitor Formation   [ Time Frame: Baseline up to a mean duration of 54 months ]

6.  Secondary:   Mean Annual ReFacto Consumption Per Patient Year   [ Time Frame: Baseline up to a mean duration of 54 months ]

7.  Secondary:   Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success   [ Time Frame: Baseline up to a mean duration of 54 months ]

8.  Secondary:   Number of Participants for Physicians' Assessment of Efficacy   [ Time Frame: Baseline up to a mean duration of 54 months ]

9.  Secondary:   Number of Participants for Patients' Assessment of Efficacy   [ Time Frame: Baseline up to a mean duration of 54 months ]

10.  Secondary:   Number of Participants for Physicians' Assessment of Tolerance   [ Time Frame: Baseline up to a mean duration of 54 months ]

11.  Secondary:   Number of Participants for Patients' Assessment of Tolerance   [ Time Frame: Baseline up to a mean duration of 54 months ]

12.  Secondary:   Number of Participants for Physicians' Assessment of Handling of ReFacto   [ Time Frame: Baseline up to a mean duration of 54 months ]

13.  Secondary:   Number of Participants for Patients' Assessment of Handling of ReFacto   [ Time Frame: Baseline up to a mean duration of 54 months ]

14.  Secondary:   Number of Participants for Days of Sick Leave Per Month   [ Time Frame: Baseline up to a mean duration of 54 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00195442     History of Changes
Other Study ID Numbers: 3082A-100690
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: January 12, 2011
Results First Posted: February 7, 2011
Last Update Posted: February 11, 2011