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CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
NCT01095510 · View on ClinicalTrials.gov ↗
Study Summary
The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.
Conditions Studied
Interventions
- BIOLOGICAL CINRYZE
Study Locations (11)
Other
- Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy — Berlin
- Klinikum rechts der Isar, Technical University Munich, ENT Clinic — Munich
- Semmelweis University, Allergy and Angioedema Outpatients Clinic, Kútvölgyi Clinical Center — Budapest
Oregon
- Allergy & Asthma Research Group — Eugene
- Baker Allergy, Asthma and Dermatology Research Center, LLC — Lake Oswego
Texas
- AARA Research Center — Dallas
- Allergy and Asthma Research Center, P.A. — San Antonio
Colorado
- Asthma & Allergy Associates, P.C. — Colorado Springs
Florida
- University of South Florida Asthma, Allergy and Immunology Clinical Research Unit — Tampa
Maryland
- Institute for Asthma and Allergy, PC — Chevy Chase
Washington
- Marycliff Allergy Specialists — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-06-02 |
| Est. Completion | 2012-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01095510
The ClinicalTrials.gov registry entry for NCT01095510 describes a study currently listed as completed. It is categorized as Phase 2, 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 9 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 1 intervention — of which CINRYZE 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: NCT01095510 reports 11 study locations spanning 7 distinct geographic areas — top geographies include Other, Oregon, Texas. 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 NCT01095510 about?
NCT01095510 is a clinical study titled "CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12". The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary...
What is the current status of trial NCT01095510?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-06-02. Estimated completion is 2012-04-17.
What conditions does trial NCT01095510 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 NCT01095510?
The interventions under investigation include: CINRYZE (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01095510?
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 NCT01095510 being conducted?
This trial has 11 study locations across Colorado, Florida, Maryland, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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