WithdrawnPhase 2

Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema

Stopped: PI indicated departure from institution, inability to complete study.

United States0Started 2013-08

Plain-language 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).

Who can participate

Age range2 Years – 16 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Measurement of time to symptomatic improvement from acute attacks of hereditary angioedema

Timeframe: 28 days

Trial details

NCT IDNCT01832896

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Hereditary Angioedema Types I and II trials