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NCT01095497 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
A Phase 2 study of Hereditary Angioedema, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 7
- Study locations
NCT01095497 is a Phase 2 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 26 participants, below the 74-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (65% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT01095497, a Phase 2 study of Hereditary Angioedema, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 7
- Study locations
Study Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration
Conditions Studied
Interventions
- BIOLOGICAL CINRYZE
Study Locations (7)
Arizona
- Allergy, Asthma and Immunology Associates - Scottsdale
California
- Allergy and Asthma Clinical Research, Inc. - Walnut Creek
Georgia
- Family Allergy and Asthma Center - Atlanta
Maryland
- Institute for Asthma and Allergy - Chevy Chase
Oregon
- Allergy, Asthma and Dermatology Research Center - Lake Oswego
Texas
- AARA Research Center - Dallas
Washington
- Marycliff Allergy Specialists - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-06-07 |
| Est. Completion | 2010-12-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01095497
The ClinicalTrials.gov registry entry for NCT01095497 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 74-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (65% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 1 intervention - of which CINRYZE is the first listed.
NCT01095497 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01095497 about?
NCT01095497 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration". The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenici...
What is the current status of trial NCT01095497?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-06-07. Estimated completion is 2010-12-16.
What conditions does trial NCT01095497 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT01095497?
The interventions under investigation include: CINRYZE (BIOLOGICAL).
Who is sponsoring clinical trial NCT01095497?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01095497 being conducted?
This trial has 7 study locations across Arizona, California, Georgia, Maryland, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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