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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01832896
Other study ID # DX-88/IST-5
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date August 2013
Est. completion date December 2017

Study information

Verified date January 2017
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 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


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ecallantide subcutaneous dosing
For acute attacks of Hereditary Angioedema in children and adolescents, Ecallantide will be administered.

Locations

Country Name City State
United States Winthrop-University Hosptial Clinical Trials Center Mineola New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health Dyax Corp.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT01912456 - A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Phase 3
Completed NCT01760343 - A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Phase 1
Completed NCT04618211 - Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Phase 2
Recruiting NCT06343779 - Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT02316353 - A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Phase 3
Recruiting NCT05396105 - Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Phase 2/Phase 3
Completed NCT01576523 - A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route Phase 1/Phase 2
Active, not recruiting NCT05047185 - Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II Phase 2