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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dyax Corp.
ClinicalTrials.gov Identifier:
NCT01253382
First received: December 2, 2010
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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

Condition Intervention Phase
Hereditary Angioedema
Biological: ecallantide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Angioedema (HAE)

Resource links provided by NLM:


Further study details as provided by Dyax Corp.:

Primary Outcome Measures:
  • safety and tolerability of ecallantide [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluate the PK profile of ecallantide [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • assess the efficacy of ecallantide [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ecallantide Biological: ecallantide
10 - 30mg subcutaneous injection.
Placebo Comparator: placebo
phosphate buffered saline
Biological: ecallantide
10 - 30mg subcutaneous injection.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dyax Corp.
ClinicalTrials.gov Identifier: NCT01253382     History of Changes
Other Study ID Numbers: DX-88/26, 2010-022716-39
Study First Received: December 2, 2010
Last Updated: July 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Angioedemas, Hereditary
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 22, 2014