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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ViroPharma

ClinicalTrials.gov Identifier:

NCT01095497

First received: February 22, 2010

Last updated: February 7, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2010
Last Updated Date	February 7, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 7, 2012)	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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: March 26, 2010)	C1INH and C4 Levels [ Time Frame: Through 18 days post first dose ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01095497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 7, 2012)	C1 Inhibitor (C1INH) and C4 Levels [ Time Frame: 18 days in each treatment period ] [ Designated as safety issue: No ] Number of Subjects With C1INH Antibodies [ Time Frame: 18 days in each treatment period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 26, 2010)	Anti C1INH Antibodies [ Time Frame: Through 18 days post first dose ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Official Title ^ICMJE	An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With Hereditary Angioedema (HAE)
Brief Summary	The objectives of the study are to: Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection Assess the immunogenicity of CINRYZE following subcutaneous administration
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Hereditary Angioedema
Intervention ^ICMJE	Biological: CINRYZE C1 inhibitor (human)
Study Arm (s)	Experimental: IV CINRYZE First, Then SC CINRYZE Dose 1 Intervention: Biological: CINRYZE Experimental: IV CINRYZE First, Then SC CINRYZE Dose 2 Intervention: Biological: CINRYZE
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	26
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: To be eligible for this protocol, a subject must: Have a confirmed diagnosis of HAE. During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) treated with C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic acid), IV fluids, or narcotic analgesics. Agree to strictly adhere to the protocol-defined schedule of assessments and procedures. Exclusion Criteria: To be eligible for this protocol, a subject must not: Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose. If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose. Have a history of abnormal blood clotting or other coagulopathy. Have a history of allergic reaction to CINRYZE or other blood products. Be pregnant or breastfeeding. Have received an immunization within 30 days prior to the first dose. Have participated in any other investigational drug study within 30 days prior to the first dose.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01095497
Other Study ID Numbers ^ICMJE	0624-200
Has Data Monitoring Committee	No
Responsible Party	ViroPharma
Study Sponsor ^ICMJE	ViroPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ViroPharma
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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