Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

NCT ID: NCT00432510

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-09
• Study Completion Date: 2007-02-28

Brief Summary

The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.

Conditions

Hereditary Angioedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Dose

1,000 Units (U) of C1INH-nf administered intravenously (IV).

Group Type: EXPERIMENTAL

C1 esterase inhibitor [human] (C1INH-nf)

Intervention Type: DRUG

First Dose Followed by Second Dose

1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.

Group Type: EXPERIMENTAL

C1 esterase inhibitor [human] (C1INH-nf)

Intervention Type: DRUG

Interventions

C1 esterase inhibitor [human] (C1INH-nf)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Enrolled in LEVP2005-1 (current or in the past)

Exclusion Criteria

• C1 inhibitor infusion within the last 7 days
• Signs of any HAE attack
• HAE attack within 7 days before actual infusion of C1INH-nf
• Change in the dosage of androgens in the last 14 days before the study
• Use of antifibrinolytics in the last 7 days before the study
• Change in oral conceptive medication in the last two months before the study
• History of clinically relevant antibody development to C1 inhibitor
• Use of oral anticoagulant medication in the last 14 days
• Use of heparin within the last two days prior to the study
• History of allergic reaction to C1 inhibitor or other blood products
• Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals
• Pregnancy or lactation
• B-cell malignancy
• Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

University of California, San Diego

San Diego, California, United States

Allergy and Asthma Clinical Research, Inc.

Walnut Creek, California, United States

Family Allergy and Asthma Center

Atlanta, Georgia, United States

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Penn State University

Hershey, Pennsylvania, United States

AARA Research Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

LEVP2006-5

Identifier Type: -

Identifier Source: org_study_id