A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Public ClinicalTrials.gov record NCT01386658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
Study identification
- NCT ID
- NCT01386658
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 27, 2012 (Actual)
- Primary completion
- Mar 12, 2018 (Actual)
- Completion
- Mar 12, 2018 (Actual)
- Last update posted
- Jun 8, 2021
2012 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| University of South Florida | Tampa | Florida | 33613 | — |
| Breathe America | Shreveport | Louisiana | 71106 | — |
| Institute for Asthma and Allergy, PC | Chevy Chase | Maryland | 20815 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Washington University School of Medicine | St Louis | Missouri | 63141 | — |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45231 | — |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | — |
| Oklahoma Institute of Allergy and Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | — |
| Allergy Asthma Dermatology Research Center | Lake Oswego | Oregon | 97035 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01386658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01386658 live on ClinicalTrials.gov.