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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Hereditary Angioedema Types I and II
Interventions
BIOLOGICAL

C1-esterase inhibitor - single intravenous dose

A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.

BIOLOGICAL

C1-esterase inhibitor - subcutaneous low dose

A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.

BIOLOGICAL

C1-esterase inhibitor - subcutaneous medium dose

A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.

BIOLOGICAL

C1-esterase inhibitor - subcutaneous high dose

A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.

Trial Locations (8)

10117

Study Site, Berlin

19108

Study Site, Hershey

20815

Study Site, Chevy Chase

30342

Study Site, Atlanta

43617

Study Site, Toledo

45231

Study Site, Cincinnati

55101

Study Site, Mainz

60596

Study Site, Frankfurt

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

CSL Behring

INDUSTRY