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

This study has been completed.

Sponsor:

Information provided by:

ViroPharma

ClinicalTrials.gov Identifier:

NCT00462709

First received: April 17, 2007

Last updated: May 7, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 17, 2007

Last Updated Date

May 7, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of All HAE Attacks [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.

Original Primary Outcome Measures ^ICMJE

The presence or absence of unequivocal beginning of relief of the defining symptom within 4 hours.

Change History

Complete list of historical versions of study NCT00462709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Change in time to the unequivocal beginning of relief of the defining symptom for subjects who receive multiple treatments.
The ability of C1INH-nf concentrate to raise C1INH and C4 levels.
Safety will be assessed by the number and severity of adverse experiences, and changes in clinical laboratory safety parameters.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

Brief Summary

The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hereditary Angioedema

Intervention ^ICMJE

Biological: C1 esterase inhibitor [human] (C1INH-nf)

Study Arm (s)

Experimental: Open-label C1INH-nf

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

Intervention: Biological: C1 esterase inhibitor [human] (C1INH-nf)

Publications *

* 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

146

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

- History of at least 1 HAE attack per month or any history of laryngeal edema

In addition, this study was open to all subjects who:

Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
Were excluded from LEVP2005-1 for any of the following reasons:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of anti-C1 inhibitor (C1INH) autoantibodies
Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:
- Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
- Had a known HAE-causing C1INH mutation, or
- Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

History of allergic reaction to C1INH or other blood products
Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
Received blood or a blood product in the past 60 days other than C1INH-nf

Gender

Both

Ages

1 Year and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00462709

Other Study ID Numbers ^ICMJE

LEVP2006-4

Has Data Monitoring Committee

Not Provided

Responsible Party

Chief Scientific Officer, ViroPharma

Study Sponsor ^ICMJE

ViroPharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bruce Zuraw, MD

University of California, San Diego

Information Provided By

ViroPharma

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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