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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: Completed Phase 2 study of Hereditary Angioedema, sponsored by Shire.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01095497 record still lists
NCT01095497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 74-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (65% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Hereditary Angioedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01095497's enrollment target sits among peer trials
26 13th of 14 higher than 2 of 14 other Hereditary Angioedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hereditary Angioedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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