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Clinical Trials/NCT01576523
NCT01576523
Completed
Phase 1

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

CSL Behring1 site in 1 country18 target enrollmentStarted: April 2012Last updated:
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ConditionsHereditary Angioedema Types I and II

Overview

Phase
Phase 1
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Modeled C1-esterase Inhibitor Functional Activity Trough Level
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Modeled C1-esterase Inhibitor Functional Activity Trough Level

Time Frame: at the fourth week of each dosing regimen

Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation

Secondary Outcomes

  • As-observed C1-esterase Inhibitor Functional Activity Trough Level(during the last week of 4-week dose regimen)
  • C1-esterase Inhibitor Concentration Trough Level(during the last week of 4-week dose regimen)
  • C4 Concentration Trough Level(during the last week of 4-week dose regimen)
  • Change From Baseline in C1-esterase Inhibitor Functional Activity(Baseline and during the last week of 4-week dose regimen)
  • Change From Baseline in C1-esterase Inhibitor Concentration(Baseline and during the last week of 4-week dose regimen)
  • Change From Baseline in C4 Concentration(Baseline and during the last week of 4-week dose regimen)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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