Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks - Study Results

Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)

This study has been completed.

Study NCT00462709 Information provided by ViroPharma

First Received on April 17, 2007. Last Updated on May 7, 2010 History of Changes

Results First Received: March 31, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Hereditary Angioedema
Intervention:	Biological: C1 esterase inhibitor [human] (C1INH-nf)

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
Open-label C1INH-nf	1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.

Participant Flow: Overall Study

	Open-label C1INH-nf
STARTED	146
COMPLETED	79
NOT COMPLETED	67
Transitioned to commercial C1INH-nf	40
Lost to Follow-up	10
Withdrawal by Subject	8
Transferred to LEVP2006-1 (NCT00438815)	3
Death	2
Logistical reasons	2
Physician Decision	1
Withdrew to start treatment with Cetor	1

Baseline Characteristics

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Reporting Groups

	Description
Open-label C1INH-nf	1,000 U of C1INH-nf administered IV every 3 to 7 days.

Baseline Measures

	Open-label C1INH-nf
Number of Participants [units: participants]	146
Age [units: years] Mean ± Standard Deviation	36.5 ± 16.48
Gender [units: participants]
Female	112
Male	34

Outcome Measures

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1. Primary:

Frequency of All HAE Attacks [ Time Frame: Duration of the study ]

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2. Other Pre-specified:

Antigenic C1 Inhibitor (C1INH) Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]

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3. Other Pre-specified:

Functional C1INH Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]

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4. Other Pre-specified:

Complement C4 Serum Levels [ Time Frame: Pre-infusion to 1 hour post-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: Clinical Study Agreement. Most restrictive provision - PI will not publish results until after first of: multicenter publication is published or 24 months from study end. Thereafter, PI may publish his results. PI must provide copy of proposed publication to sponsor for pre-review. If sponsor requests, PI must delete sponsor confidential information before publication and/or delay publication for 90 days so sponsor can file for patents or take other action to protect its patent rights.

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: Chief Scientific Officer
Organization: ViroPharma
phone: 610-458-7300

No publications provided by ViroPharma

Publications automatically indexed to this study:

Zuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, Craig T, Grant JA, Hurewitz D, Bielory L, Cartwright WE, Koleilat M, Ryan W, Schaefer O, Manning M, Patel P, Bernstein JA, Friedman RA, Wilkinson R, Tanner D, Kohler G, Gunther G, Levy R, McClellan J, Redhead J, Guss D, Heyman E, Blumenstein BA, Kalfus I, Frank MM. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):513-22.

Responsible Party:	Chief Scientific Officer, ViroPharma
ClinicalTrials.gov Identifier:	NCT00462709 History of Changes
Other Study ID Numbers:	LEVP2006-4
Study First Received:	April 17, 2007
Results First Received:	March 31, 2010
Last Updated:	May 7, 2010
Health Authority:	United States: Food and Drug Administration