Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

Hereditary Angioedema Clinical Trial

Official title:

Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432510
• Other study ID #: LEVP2006-5
• Status: Completed
• Phase: Phase 1
• Start date: October 9, 2006
• Est. completion date: February 28, 2007

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 28, 2007
• Est. primary completion date: February 28, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

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

Locations

Country	Name	City	State
United States	Family Allergy and Asthma Center	Atlanta	Georgia
United States	AARA Research Center	Dallas	Texas
United States	Penn State University	Hershey	Pennsylvania
United States	University of California, San Diego	San Diego	California
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Institute for Asthma and Allergy	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.		1 week
Primary	C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.		1 week
Secondary	Number and severity of adverse events.		3 months
Secondary	Change in clinical laboratory safety parameters from pre- to post-infusion.		3 months
Secondary	Change in vital signs from pre- to post-infusion.		30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)