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EASSI - Evaluation of the Safety of Self-Administration With Icatibant

NCT00997204 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-06-11

Study results available
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Summary

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Conditions

Interventions

DRUG

Icatibant

Single subcutaneous injection of icatibant, 30 mg

Sponsors & Collaborators

  • Jerini AG

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-25
Primary Completion
2011-06-22
Completion
2011-06-22

Countries

  • Argentina
  • Austria
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00997204 on ClinicalTrials.gov