Last updated: May 14, 2021
Sponsor: Shire
Overall Status: Trial Not Available
Phase
2/3
Condition
Allergy
Hives (Urticaria)
Allergies & Asthma
Treatment
N/AClinical Study ID
NCT01253382
DX-88/26
2010-022716-39
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female from 2 years of age and prepubertal
- 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
- 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.
- Must have signed informed consent by parent or caregiver.
Exclusion
Exclusion Criteria:
- <2 years of age or have reached puberty
- Received treatment with ecallantide within previous 72 hours
- Received an investigational drug or device, other than ecallantide, within 30 daysprior to the screening visit
- Pharyngeal/laryngeal symptoms
- Mild attacks including mild edema of the extremities and mild abdominal attacks
- Are unable or unwilling to give informed consent (parent or caregiver)
- 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: