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



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:7/29/2017
Start Date:April 2012
End Date:December 2012

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An Open-label, Cross-over, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of the Subcutaneous Administration of a Human Plasma-derived C1-esterase Inhibitor in Subjects With Hereditary Angioedema

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.


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.
We found this trial at
6
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805
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Toledo, OH
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801
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Atlanta, GA
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4961
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Berlin,
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1123
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Chevy Chase, MD
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726
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from
Cincinnati, OH
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1147
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Hershey, PA
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