A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01095497

First received: February 22, 2010

Last updated: April 24, 2014

Last verified: April 2014

History of Changes

Results First Received: December 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Hereditary Angioedema
Intervention:	Biological: CINRYZE

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
IV CINRYZE First, Then SC CINRYZE Dose 1	Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
IV CINRYZE First, Then SC CINRYZE Dose 2	Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.

Participant Flow for 2 periods

Period 1: Intravenous CINRYZE

	IV CINRYZE First, Then SC CINRYZE Dose 1	IV CINRYZE First, Then SC CINRYZE Dose 2
STARTED	14	12
COMPLETED	13	12
NOT COMPLETED	1	0

Period 2: Subcutaneous CINRYZE

	IV CINRYZE First, Then SC CINRYZE Dose 1	IV CINRYZE First, Then SC CINRYZE Dose 2
STARTED	13	12
COMPLETED	12	12
NOT COMPLETED	1	0

Baseline Characteristics

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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.
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Reporting Groups

	Description
IV CINRYZE First, Then SC CINRYZE Dose 1	Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
IV CINRYZE First, Then SC CINRYZE Dose 2	Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
Total	Total of all reporting groups

Baseline Measures

	IV CINRYZE First, Then SC CINRYZE Dose 1	IV CINRYZE First, Then SC CINRYZE Dose 2	Total
Overall Participants Analyzed [Units: Participants]	14	12	26

Age [Units: Years] Mean (Standard Deviation)	28.6 (12.70)	37.3 (15.92)	32.7 (14.66)

Gender [Units: Participants]
Female	7	8	15
Male	7	4	11

Outcome Measures

1. Primary:

Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. [ Time Frame: 18 days in each treatment period ]

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2. Secondary:

C1 Inhibitor (C1INH) and C4 Levels [ Time Frame: 18 days in each treatment period ]

Results not yet reported. Anticipated Reporting Date: No text entered.

3. Secondary:

Number of Subjects With C1INH Antibodies [ Time Frame: 18 days in each treatment period ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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 60 days so Sponsor can file for patents or take other action to protect its patent rights.

Results Point of Contact:

Name/Title: Chief Scientific Officer
Organization: ViroPharma
phone: 610-458-7300

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01095497 History of Changes
Other Study ID Numbers:	0624-200
Study First Received:	February 22, 2010
Results First Received:	December 23, 2011
Last Updated:	April 24, 2014

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