Clinical Trial: Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous Ecallantide in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angi

Brief Summary:

The primary objective of this study is:

  • assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE

The secondary objectives are:

  • evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE
  • assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: safety and tolerability of ecallantide [ Time Frame: 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • evaluate the PK profile of ecallantide [ Time Frame: 4 years ]
  • assess the efficacy of ecallantide [ Time Frame: 4 years ]


Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: December 2, 2010
Date Started: June 2012
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016