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

Last updated: May 14, 2021
Sponsor: Shire
Overall Status: Trial Not Available

Phase

2/3

Condition

Allergy

Hives (Urticaria)

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT01253382
DX-88/26
2010-022716-39
  • Ages 2-17
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female from 2 years of age and prepubertal
  2. Physician diagnosis and history of HAE (Type I or II) including laboratory resultsshowing C1-1NH activity below the lower limit of normal or up to 15% above the lowerlimit of the normal range
  3. Present at the site with moderate to severe signs and symptoms of an acute attack ofHAE within 8 hours of recognition of the onset of the attack. Spontaneous resolutionof the attack must not have begun before the administration of study drug.
  4. Must have signed informed consent by parent or caregiver.

Exclusion

Exclusion Criteria:

  1. <2 years of age or have reached puberty
  2. Received treatment with ecallantide within previous 72 hours
  3. Received an investigational drug or device, other than ecallantide, within 30 daysprior to the screening visit
  4. Pharyngeal/laryngeal symptoms
  5. Mild attacks including mild edema of the extremities and mild abdominal attacks
  6. Are unable or unwilling to give informed consent (parent or caregiver)
  7. Any other condition that, in the opinion of the investigator, may compromise thesafety or compliance of the patient or would preclude the patient from successfulcompletion of the study

Study Design

Study Start date:
June 01, 2012
Estimated Completion Date: