Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Hereditary Angioedema
• Intervention / Treatment: Drug: C1 esterase inhibitor [human] (C1INH-nf)

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093-0732
      • University of California, San Diego
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Family Allergy and Asthma Center
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Institute for Asthma and Allergy
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University
  • Texas
    • Dallas, Texas, United States, 75231
      • AARA Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose; 1,000 Units (U) of C1INH-nf administered intravenously (IV).	Drug: C1 esterase inhibitor [human] (C1INH-nf)
Experimental: 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.	Drug: C1 esterase inhibitor [human] (C1INH-nf)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.	1 week
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 Outcome Measures

Outcome Measure	Time Frame
Number and severity of adverse events.	3 months
Change in clinical laboratory safety parameters from pre- to post-infusion.	3 months
Change in vital signs from pre- to post-infusion.	30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2006
• Primary Completion (Actual): February 28, 2007
• Study Completion (Actual): February 28, 2007

Study Registration Dates

• First Submitted: February 7, 2007
• First Submitted That Met QC Criteria: February 7, 2007
• First Posted (Estimate): February 8, 2007

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hereditary angioedema; C1 esterase inhibitor (human)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Angioedema; Angioedemas, Hereditary; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Complement Inactivating Agents; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins; Complement C1s
• Other Study ID Numbers: LEVP2006-5