Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema

Hereditary Angioedema (HAE) Clinical Trial

Official title:

A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous Ecallantide in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angioedema (HAE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01253382
• Other study ID #: DX-88/26
• Secondary ID: 2010-022716-39
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 1, 2012

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is:

• assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE

The secondary objectives are:

• evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE

• assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Male or female from 2 years of age and prepubertal

2. Physician diagnosis and history of HAE (Type I or II) including laboratory results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range

3. Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.

4. Must have signed informed consent by parent or caregiver.

Exclusion Criteria:

1. <2 years of age or have reached puberty

2. Received treatment with ecallantide within previous 72 hours

3. Received an investigational drug or device, other than ecallantide, within 30 days prior to the screening visit

4. Pharyngeal/laryngeal symptoms

5. Mild attacks including mild edema of the extremities and mild abdominal attacks

6. Are unable or unwilling to give informed consent (parent or caregiver)

7. Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Biological:
• ecallantide
10 - 30mg subcutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of ecallantide		4 years
Secondary	evaluate the PK profile of ecallantide		4 years
Secondary	assess the efficacy of ecallantide		4 years