Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432510
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : March 20, 2014
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: C1 esterase inhibitor [human] (C1INH-nf) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
Study Start Date : October 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2007

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)

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432510

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

Responsible Party: Chief Scientific Officer, ViroPharma Identifier: NCT00432510     History of Changes
Other Study ID Numbers: LEVP2006-5
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Shire:
Hereditary angioedema
C1 esterase inhibitor (human)

Additional relevant MeSH terms:
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Genetic Diseases, Inborn
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents