Status:
WITHDRAWN
Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Dyax Corp.
Conditions:
Hereditary Angioedema Types I and II
Eligibility:
All Genders
2-16 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and tolerability of a single Subcutaneous (SC) dose of Ecallantide in children and adolescents with Hereditary Angioedema (HAE).
Detailed Description
This pilot study is an open-label, non-randomized, single-arm study to evaluate the tolerability and safety of a single SC administration of ecallantide in up to approximately 10 pediatric subjects wi...
Eligibility Criteria
Inclusion
- 2 through 15 years of age, inclusive (ie, from the second birthday through the day prior to the sixteenth birthday) at the time of the subject's first attack.
- Documented diagnosis of HAE type I or II. Diagnosis must be confirmed by a documented immunogenic (below the lower limit of normal) and/or functional (\< 50% of normal levels) C1- Inhibitor deficiency. Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening.
- Informed consent (and subject assent as appropriate) signed by the subject's parent(s) or legal guardian(s).
Exclusion
- History of an adverse reaction (AE) to Ecallantide in the past
- Diagnosis of angioedema other than HAE
- Participation in another clinical study during the 30 days prior to treatment
- Any known factor/disease that might interfere with the treatment compliance, study conduct, or result interpretation
- Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
- Treatment with angiotensin converting enzyme (ACE) inhibitors within 7 days prior to treatment.
- Use of hormonal contraception within the 90 days prior to treatment for females of childbearing potential
- The subject is pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01832896
Start Date
August 1 2013
End Date
December 1 2017
Last Update
March 31 2023
Active Locations (1)
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1
Winthrop-University Hosptial Clinical Trials Center
Mineola, New York, United States, 11501