Trials / Withdrawn
WithdrawnNCT01253382
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
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)
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ecallantide | 10 - 30mg subcutaneous injection. |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2015-04-01
- First posted
- 2010-12-03
- Last updated
- 2021-05-18
Source: ClinicalTrials.gov record NCT01253382. Inclusion in this directory is not an endorsement.