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

NCT01576523 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-02-01

Study results available
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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.

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Global Clinical Program Director · CSL Behring

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576523 on ClinicalTrials.gov