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WithdrawnNCT01253382Updated May 18, 2021

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

A Phase 2/3 interventional study of ecallantide in Hereditary Angioedema (HAE), sponsored by Shire. Withdrawn. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-18.

Sponsored by Shire · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

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
02

Conditions studied

  • Hereditary Angioedema (HAE)
03

In context

Angioedema

164 studies on the registry are indexed under Angioedema; 19 are open to participants now.

Browse Angioedema studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range
  3. Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.
  4. Must have signed informed consent by parent or caregiver.

Exclusion criteria

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 days prior 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 the safety or compliance of the patient or would preclude the patient from successful completion of the study
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    ecallantide

    Biological: ecallantide

  • Placebo comparator
    placebo

    phosphate buffered saline

    Biological: ecallantide

Interventions

  • Biologicalecallantide

    10 - 30mg subcutaneous injection.

06

What researchers measure

Primary outcomes

  1. safety and tolerability of ecallantide

    Time frame: 4 years

Secondary outcomes

  1. evaluate the PK profile of ecallantide

    Time frame: 4 years

  2. assess the efficacy of ecallantide

    Time frame: 4 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01253382
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Jun 1, 2012
Primary completion
Apr 1, 2015 (estimated)
Last update
May 18, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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