NCT00432510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2007

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

February 7, 2007

Last Update Submit

June 1, 2021

Conditions

Hereditary Angioedema

Keywords

Hereditary angioedemaC1 esterase inhibitor (human)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

Single Dose

EXPERIMENTAL

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

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

First Dose Followed by Second Dose

EXPERIMENTAL

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)

Interventions

C1 esterase inhibitor [human] (C1INH-nf)DRUG
First Dose Followed by Second DoseSingle Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California, San Diego

San Diego, California, 92093-0732, United States

Location

Allergy and Asthma Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Family Allergy and Asthma Center

Atlanta, Georgia, 30342, United States

Location

Institute for Asthma and Allergy

Wheaton, Maryland, 20902, United States

Location

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

Complement C1 Inhibitor Protein

Condition Hierarchy (Ancestors)

AngioedemaVascular DiseasesCardiovascular DiseasesHereditary Complement Deficiency DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesImmunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesComplement C1 Inactivator ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsComplement Inactivator ProteinsComplement System ProteinsImmunoproteinsBlood ProteinsProteins

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 8, 2007

Study Start

October 9, 2006

Primary Completion

February 28, 2007

Study Completion

February 28, 2007

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

US(6)