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NCT01426763 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
A Phase 2 study of Hereditary Angioedema, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 4
- Study locations
NCT01426763 is a Phase 2 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 12 participants, below the 75-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01426763, a Phase 2 study of Hereditary Angioedema, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
Conditions Studied
Interventions
- BIOLOGICAL CINRYZE with rHuPH20
Study Locations (4)
Arizona
- ViroPharma Investigational Site - Scottsdale
California
- ViroPharma Investigational Site - Walnut Creek
Georgia
- ViroPharma Investigational Site - Atlanta
Texas
- ViroPharma Investigational Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-09-12 |
| Est. Completion | 2011-11-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01426763
The ClinicalTrials.gov registry entry for NCT01426763 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 75-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (84% 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 with rHuPH20 is the first listed.
NCT01426763 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Arizona, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01426763 about?
NCT01426763 is a clinical study titled "A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase". The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the phar...
What is the current status of trial NCT01426763?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-09-12. Estimated completion is 2011-11-28.
What conditions does trial NCT01426763 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT01426763?
The interventions under investigation include: CINRYZE with rHuPH20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01426763?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01426763 being conducted?
This trial has 4 study locations across Arizona, California, Georgia, Texas. 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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