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NCT00914966 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00914966: Completed Phase 4 study, sponsored by Shire.
NCT00914966 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00914966, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3. To assess the immunogenicity of CINRYZE.
Primary Outcome
Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.
Interventions
- BIOLOGICAL C1 inhibitor (human) [C1 INH]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-08-31 |
| Est. Completion | 2012-05-24 |
| Phase | Phase 4 |
What the finished NCT00914966 record still lists
NCT00914966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which C1 inhibitor (human) [C1 INH] is the first listed.
NCT00914966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00914966 about?
NCT00914966 is a clinical study titled "A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE". The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3. To assess the immunogenicity of CINRYZE.
What is the current status of trial NCT00914966?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2009-08-31. Estimated completion is 2012-05-24.
What interventions are being tested in trial NCT00914966?
The interventions under investigation include: C1 inhibitor (human) [C1 INH] (BIOLOGICAL).
Who is sponsoring clinical trial NCT00914966?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00914966's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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