A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Behring

ClinicalTrials.gov Identifier:

NCT00885742

First received: April 21, 2009

Last updated: July 10, 2012

Last verified: June 2012

History of Changes

Results First Received: April 30, 2012

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

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
FXIII	All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).

Participant Flow: Overall Study

	FXIII
STARTED	41
COMPLETED	41
NOT COMPLETED	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII‑Containing Product to Treat the Bleeding Event) [ Time Frame: Up to week 52 ]

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2. Secondary:

Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels [ Time Frame: 12 months ]

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3. Secondary:

Adverse Events [ Time Frame: 12 months ]

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4. Secondary:

Peak FXIII Concentration at Steady State [ Time Frame: At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion. ]

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5. Secondary:

Trough FXIII Concentration at Steady State [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion. ]

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6. Secondary:

Time to Peak Concentration [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion. ]

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7. Secondary:

Incremental Recovery [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion. ]

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8. Secondary:

Achievement of Trough Factor XIII Levels of 5% or Higher. [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion. ]

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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:	NCT00885742 History of Changes
Other Study ID Numbers:	BI71023_3001, 1482, 2009-010722-19
Study First Received:	April 21, 2009
Results First Received:	April 30, 2012
Last Updated:	July 10, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Spain: Spanish Agency of Medicines

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