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Protease Inhibitor
Ecallantide for Hereditary Angioedema
Phase 2
Waitlist Available
Led By Mark A Davis-Lorton, MD
Research Sponsored by Mark Davis-Lorton, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study 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).
Eligible Conditions
- Hereditary Angioedema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of time to symptomatic improvement from acute attacks of hereditary angioedema
Secondary outcome measures
Number of Partcipants with Adverse Events
Side effects data
From 2007 Phase 3 trial • 91 Patients • NCT0026208011%
Headache
8%
Hereditary Angioedema
8%
Pyrexia
8%
Diarrhoea
6%
Tachycardia
6%
Nasal Congestion
6%
Nasopharyngitis
3%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Placebo
Double Blind - Ecallantide
Repeat-Dosing Ecallantide
Trial Design
1Treatment groups
Experimental Treatment
Group I: EcallantideExperimental Treatment1 Intervention
Study Medication, Dose, and Mode of Administration:
Single dose of ecallantide subcutaneous dosing:
Age less than 10: Weight <25 Kg: 10mg subcutaneously at one site; 25-50kg: 20mg subcutaneously, 10mg per site for 2 separate sites; >50 kg 30mg subcutaneously, 10mg per site for 3 separate sites. Dosing will not exceed 30mg.
Age greater than 10: 10mg per site for 3 separate sites. Dosing will not exceed 30mg.
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Who is running the clinical trial?
Mark Davis-Lorton, MDLead Sponsor
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,598 Total Patients Enrolled
Dyax Corp.Industry Sponsor
3 Previous Clinical Trials
207 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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