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

History of Changes

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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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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

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

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Measure Type	Primary
Measure Title	Number of Participants With Factor VIII (FVIII) Inhibitor Development
Measure Description	Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
Time Frame	Day 1 and Month 6 or Early Termination Visit
Safety Issue	Yes

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.
The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.

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.

Measured Values

	Xyntha
Number of Participants Analyzed [units: participants]	51
Number of Participants With Factor VIII (FVIII) Inhibitor Development [units: Participants]
MTP (n=34)	6
PTP (n=17)	1

No statistical analysis provided for Number of Participants With Factor VIII (FVIII) Inhibitor Development

4. Secondary:

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

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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8. Other Pre-specified:

Frequency of Xyntha Infusions Required Per Hemorrhage [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]

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9. Other Pre-specified:

Average Dose of Xyntha Infusions Required Per Hemorrhage [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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.

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

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