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Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
NCT02052141 · View on ClinicalTrials.gov ↗
Study Summary
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE). Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
Conditions Studied
Interventions
- BIOLOGICAL CINRYZE 500
- BIOLOGICAL CINRYZE 1000
Study Locations (8)
Other
- Klinikum der J.W. Goethe Universitat — Frankfurt
- HZRM Hamophilie Zentrum Rhein Main GmbH — Mörfelden-Walldorf
- Tel Aviv Sourasky Medical Center — Tel Aviv
- Instituto Nacional de Pediatria — Mexico City
- Clinical County Hospital Mures — Târgu Mureş
Colorado
- Asthma and Allergy Associates, P.C — Colorado Springs
Nevada
- Nevada Access to Research and Education Society — Las Vegas
Oregon
- Oregon Allergy Associates — Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-03-20 |
| Est. Completion | 2017-05-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052141
The ClinicalTrials.gov registry entry for NCT02052141 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hereditary Angioedema (HAE) appearing as the primary indexed condition, and to 2 interventions — of which CINRYZE 500 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02052141 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Other, Colorado, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02052141 about?
NCT02052141 is a clinical study titled "Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema". Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE). Secondary Objectives - To assess...
What is the current status of trial NCT02052141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2014-03-20. Estimated completion is 2017-05-04.
What conditions does trial NCT02052141 study?
This clinical trial studies the following conditions: Hereditary Angioedema (HAE). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02052141?
The interventions under investigation include: CINRYZE 500 (BIOLOGICAL), CINRYZE 1000 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02052141?
This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02052141 being conducted?
This trial has 8 study locations across Colorado, Nevada, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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