A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Behring

ClinicalTrials.gov Identifier:

NCT00883090

First received: April 16, 2009

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Results First Received: December 7, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Factor XIII Deficiency
Intervention:	Biological: FXIII Concentrate (Human)

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
FXIII	All subjects treated with Factor FXIII Concentrate (Human) (FXIII)

Baseline Measures

	FXIII
Number of Participants [units: participants]	14
Age [units: years] Mean ± Standard Deviation	24.0 ± 12.55
Gender [units: participants]
Female	7
Male	7

Outcome Measures

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1. Primary:

Peak FXIII Concentration at Steady State [ Time Frame: 12 weeks ]

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2. Primary:

Trough FXIII Concentration at Steady State [ Time Frame: 12 weeks ]

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3. Primary:

Time to Peak Concentration [ Time Frame: 12 weeks ]

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4. Primary:

Incremental Recovery [ Time Frame: 12 weeks ]

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5. Primary:

Terminal Half-life [ Time Frame: 12 weeks ]

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6. Primary:

Area Under the Curve at Steady State [ Time Frame: 12 weeks ]

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7. Primary:

Clearance [ Time Frame: 12 weeks ]

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8. Primary:

Volume of Distribution at Steady State [ Time Frame: 12 weeks ]

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9. Primary:

Mean Residence Time [ Time Frame: 12 weeks ]

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10. Secondary:

Adverse Events [ Time Frame: 16 weeks ]

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11. Secondary:

Laboratory Safety Parameters [ Time Frame: 16 weeks ]

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12. Secondary:

Vital Signs [ Time Frame: 16 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 investigator must provide a copy of any results communication to the sponsor for review at least 30 days prior to public release. The sponsor may request any changes necessary to prevent forfeiture of patent rights to data not in the public domain. For a multi-center study, the investigator must wait (i) at least 1 year after the study is completed at all sites or (ii) until notified by the sponsor that no multi-center publication is planned, before seeking publication review.

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
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Results Point of Contact:

Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com

No publications provided

Responsible Party:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00883090 History of Changes
Other Study ID Numbers:	BI71023_2002, 2009-010387-41, 1479
Study First Received:	April 16, 2009
Results First Received:	December 7, 2011
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration Spain: Comité Ético de Investigación Clínica

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