Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00243659

First received: October 20, 2005

Last updated: June 2, 2011

Last verified: June 2011

History of Changes

Results First Received: May 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hemophilia A
Intervention:	Biological: ReFacto AF

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 were recruited worldwide from April 2006 to April 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for a maximum of 42 days.

Reporting Groups

	Description
Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously

Participant Flow: Overall Study

	Bolus Injection	Continuous Infusion
STARTED	22	8
COMPLETED	20	5
NOT COMPLETED	2	3
Withdrawal by Subject	1	1
Protocol Violation	1	2

Baseline Characteristics

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Reporting Groups

	Description
Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously
Total	Total of all reporting groups

Baseline Measures

	Bolus Injection	Continuous Infusion	Total
Number of Participants [units: participants]	22	8	30
Age [units: years] Mean ± Standard Deviation	35.05 ± 9.51	38.13 ± 8.54	35.87 ± 9.22
Gender [units: participants]
Female	0	0	0
Male	22	8	30

Outcome Measures

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1. Primary:

Number of Patients Who Achieved Hemostatic Efficacy After Surgery [ Time Frame: 6 weeks ]

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Measure Type	Primary
Measure Title	Number of Patients Who Achieved Hemostatic Efficacy After Surgery
Measure Description	Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
Time Frame	6 weeks
Safety Issue	No

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 analysis population is the efficacy evaluable at visit three.

Reporting Groups

	Description
Bolus Injection	Approximately 50 IU/kg Refacto AF for 6 consecutive days
Continuous Infusion	Approximately 50 IU/Kg Refacto AF then continuously

Measured Values

	Bolus Injection	Continuous Infusion
Number of Participants Analyzed [units: participants]	20	5
Number of Patients Who Achieved Hemostatic Efficacy After Surgery [units: patients]
Excellent	15	3
Good	5	2
Moderate	0	0
None	0	0

No statistical analysis provided for Number of Patients Who Achieved Hemostatic Efficacy After Surgery

2. Secondary:

Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge [ Time Frame: 6 weeks ]

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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: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00243659 History of Changes
Other Study ID Numbers:	3082B2-311
Study First Received:	October 20, 2005
Results First Received:	May 29, 2009
Last Updated:	June 2, 2011
Health Authority:	European Union: European Medicines Agency United States: Food and Drug Administration

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