Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema
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|ClinicalTrials.gov Identifier: NCT01832896|
Recruitment Status : Recruiting
First Posted : April 16, 2013
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Angioedema Types I and II||Drug: Ecallantide subcutaneous dosing||Phase 2|
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 with HAE during an initial acute attack. The study is planned to enroll subjects 2 through 15 years of age who present with an acute cutaneous, abdominal, or laryngeal HAE attack. No more than 3 study sites will be included until a goal of 10 patients is achieved.
After treatment for an initial attack, one additional open label treatment with ecallantide will be offered to subjects contingent upon having been treated previously and presenting with a subsequent acute cutaneous, abdominal, or laryngeal attack of HAE at least 7 days after initial treatment. Open-label treatment for a second HAE attack will continue until 10 patients have been treated for an initial attack. Safety evaluations will be performed at each subsequent ecallantide-treated attack as for the initial treated attack
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Study Medication, Dose, and Mode of Administration:
Single dose of ecallantide subcutaneous dosing:
Drug: Ecallantide subcutaneous dosing
For acute attacks of Hereditary Angioedema in children and adolescents, Ecallantide will be administered.
- Measurement of time to symptomatic improvement from acute attacks of hereditary angioedema [ Time Frame: 28 days ]
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.
- Number of Partcipants with Adverse Events [ Time Frame: 28 Days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832896
|Contact: Mark A Davis-Lorton, MDfirstname.lastname@example.org|
|United States, New York|
|Winthrop-University Hosptial Clinical Trials Center||Recruiting|
|Mineola, New York, United States, 11501|
|Contact: Mark A Davis-Lorton, MD 516-663-2097 email@example.com|
|Principal Investigator: Mark A Davis-Lorton, MD|
|Principal Investigator:||Mark A Davis-Lorton, MD||Winthrop University Hospital|