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

NCT01253382 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2021-05-18

No results posted yet for this study

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

Conditions

  • Hereditary Angioedema (HAE)

Interventions

BIOLOGICAL

ecallantide

10 - 30mg subcutaneous injection.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2015-04-01

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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 NCT01253382 on ClinicalTrials.gov