Hereditary Angioedema Types I and II Clinical Trial
Official title:
A Multicenter, Open-Label Study to Assess the Tolerability and Safety of a Single, Subcutaneous Administration of Ecallantide in Children and Adolescents With Hereditary Angioedema
Verified date | January 2017 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. 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. 3. Informed consent (and subject assent as appropriate) signed by the subject's parent(s) or legal guardian(s). Exclusion Criteria: 1. History of an adverse reaction (AE) to Ecallantide in the past 2. Diagnosis of angioedema other than HAE 3. Participation in another clinical study during the 30 days prior to treatment 4. Any known factor/disease that might interfere with the treatment compliance, study conduct, or result interpretation 5. Congenital or acquired cardiac anomalies that interfere significantly with cardiac function. 6. Treatment with angiotensin converting enzyme (ACE) inhibitors within 7 days prior to treatment. 7. Use of hormonal contraception within the 90 days prior to treatment for females of childbearing potential 8. The subject is pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | Winthrop-University Hosptial Clinical Trials Center | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | Dyax Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of time to symptomatic improvement from acute attacks of hereditary angioedema | Time to symptom relief. Time to minimal symptoms. An improvement assessment will also be performed at each of the following timepoints: pre -treatment, every 30 minutes for the first 2 hours and then hourly through discharge and at the 28 day clinic visit.
Incidence of need for rescue medication. Incidence of worsening despite use of ecallantide. |
28 days | |
Secondary | Number of Partcipants with Adverse Events | Study Partcipants will be monitored for adverse events, changes in laboratory values, physical exam, vital sign changes and ECG changes. Vital signs, including body temperature, heart rate and sitting blood pressure, will be assessed at screening, Pre-treatment, every 30 minutes for the first 2 hours and then hourly through discharge and at the 28 day clinic visit. | 28 Days |
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