Hereditary Angioedema Types I and II

A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route

NCT01576523 | PHASE 1 | INTERVENTIONAL

The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.

8 Sites

18 Participants

Recruiting

18 Years to 8 Years

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SUBMIT

Study Site

Atlanta,Georgia,United States,30342

Study Site

Chevy Chase,Maryland,United States,20815

Study Site

Cincinnati,Ohio,United States,45231

Study Site

Toledo,Ohio,United States,43617

Study Site

Hershey,Pennsylvania,United States,19108

Study Site

Berlin,Germany,10117

Study Site

Frankfurt,Germany,60596

Study Site

Mainz,Germany,55101

Study Eligibility Criteria

Inclusion Criteria

* Males or females aged 18 years or older.
* Laboratory-confirmed hereditary angioedema type I or II.
* Less than two hereditary angioedema attacks per month in the last three months.
* Body weight of 50.0 kg to 110.0 kg.

Exclusion Criteria

* Receiving prophylactic C1-esterase inhibitor therapy.
* Received C1-esterase inhibitor, ecallantide, icatibant or any blood products for the prevention or treatment of hereditary angioedema within 7 days before the screening visit.
* Intends to use recombinant C1-esterase inhibitor or fresh frozen plasma for the acute treatment of hereditary angioedema during the study.
* Received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 30 days before the screening visit.
* Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.
* Known or suspected hypersensitivity to the study product, or to any excipients of the study product.
* Pregnancy or lactation.

Additional Studies

Additional studies can be found at ClinicalTrials.gov