Back to results

Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

Primary Purpose

Hereditary Angioedema

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

C1 esterase inhibitor [human] (C1INH-nf)

About this trial

This is an interventional other trial for Hereditary Angioedema focused on measuring Hereditary angioedema, C1 esterase inhibitor (human)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of California, San Diego
Allergy and Asthma Clinical Research, Inc.
Family Allergy and Asthma Center
Institute for Asthma and Allergy
Penn State University
AARA Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single Dose

First Dose Followed by Second Dose

Arm Description

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

1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.

Outcomes

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.

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.

Secondary Outcome Measures

Number and severity of adverse events.

Change in clinical laboratory safety parameters from pre- to post-infusion.

Change in vital signs from pre- to post-infusion.

Full Information

NCT ID

NCT00432510

First Posted

February 7, 2007

Last Updated

June 1, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00432510

Brief Title

Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

October 9, 2006 (Actual)

Primary Completion Date

February 28, 2007 (Actual)

Study Completion Date

February 28, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Angioedema

Keywords

Hereditary angioedema, C1 esterase inhibitor (human)

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Dose

Arm Type

Experimental

Arm Description

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

Arm Title

First Dose Followed by Second Dose

Arm Type

Experimental

Arm Description

1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.

Intervention Type

Drug

Intervention Name(s)

C1 esterase inhibitor [human] (C1INH-nf)

Primary Outcome Measure Information:

Title

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

Title

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Number and severity of adverse events.

Time Frame

3 months

Title

Change in clinical laboratory safety parameters from pre- to post-infusion.

Time Frame

3 months

Title

Change in vital signs from pre- to post-infusion.

Time Frame

30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92093-0732

Country

United States

Facility Name

Allergy and Asthma Clinical Research, Inc.

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Family Allergy and Asthma Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Institute for Asthma and Allergy

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Penn State University

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

AARA Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

We'll reach out to this number within 24 hrs