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A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

NCT01912456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-01-29

Study results available
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Summary

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.

Conditions

  • Hereditary Angioedema Types I and II

Interventions

BIOLOGICAL

Low-volume C1-esterase inhibitor

BIOLOGICAL

Higher-volume C1-esterase inhibitor

BIOLOGICAL

Low-volume placebo

BIOLOGICAL

Higher-volume placebo

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Global Clinical Program Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Israel
  • Italy
  • Romania
  • Spain
  • United Kingdom

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 NCT01912456 on ClinicalTrials.gov