Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00868530
First received: March 19, 2009
Last updated: April 1, 2011
Last verified: April 2011
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Biological: Xyntha

  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 recruited in China from September 2008 to December 2009.

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
Xyntha Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.

Participant Flow:   Overall Study
    Xyntha  
STARTED     53  
COMPLETED     49  
NOT COMPLETED     4  
Adverse Event                 3  
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
Xyntha Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.

Baseline Measures
    Xyntha  
Number of Participants  
[units: participants]
  53  
Age  
[units: Years]
Mean ± Standard Deviation
  23.2  ± 10.0  
Gender  
[units: Participants]
 
Female     0  
Male     53  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion   [ Time Frame: 8 hours post infusion ]

2.  Primary:   Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion   [ Time Frame: 24 hours post infusion ]

3.  Primary:   Number of Participants With Factor VIII (FVIII) Inhibitor Development   [ Time Frame: Day 1 and Month 6 or Early Termination Visit ]

4.  Secondary:   FVIII Recovery : Change From Baseline in FVIII Concentration   [ Time Frame: Day 1 and Month 6 or Early Termination Visit ]

5.  Secondary:   Number of Participants With Less Than Expected Therapeutic Effect (LETE)   [ Time Frame: 24 hours after each of 2 successive infusion, up to 6 months ]

6.  Secondary:   Number of Participants With Thrombosis Allergic-Type Reactions   [ Time Frame: Baseline up to 6 months ]

7.  Secondary:   Number of Participants With Thrombosis   [ Time Frame: Baseline up to 6 months ]

8.  Other Pre-specified:   Frequency of Xyntha Infusions Required Per Hemorrhage   [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]

9.  Other Pre-specified:   Average Dose of Xyntha Infusions Required Per Hemorrhage   [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]


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


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00868530     History of Changes
Other Study ID Numbers: 3082B2-3316, B1831015
Study First Received: March 19, 2009
Results First Received: December 3, 2010
Last Updated: April 1, 2011
Health Authority: China: Food and Drug Administration