Trial record 3 of 56 for:    "hereditary angioedema"

Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00432510
First received: February 7, 2007
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Hereditary Angioedema
Drug: C1 esterase inhibitor [human] (C1INH-nf)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 27
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432510

Locations
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
Shire
Investigators
Principal Investigator: Bruce Zuraw, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Chief Scientific Officer, ViroPharma
ClinicalTrials.gov Identifier: NCT00432510     History of Changes
Other Study ID Numbers: LEVP2006-5
Study First Received: February 7, 2007
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014