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NCT00491608 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
A Phase 3 study, sponsored by ZymoGenetics.
- Completed
- Registry status
- Phase 3
- Development phase
- 234
- Enrollment target
NCT00491608: Completed Phase 3 study, sponsored by ZymoGenetics.
NCT00491608 is a Phase 3 study that has completed, run by ZymoGenetics. The registered enrollment target is 234 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00491608, a Phase 3 study, has completed, sponsored by ZymoGenetics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 234 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
Primary Outcome
Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.
Interventions
- BIOLOGICAL rThrombin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00491608 record still lists
NCT00491608 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which rThrombin is the first listed.
NCT00491608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00491608 about?
NCT00491608 is a clinical study titled "Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis". The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
What is the current status of trial NCT00491608?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 234 participants. The study started on 2007-06. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00491608?
The interventions under investigation include: rThrombin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00491608?
This trial is sponsored by ZymoGenetics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00491608's enrollment target sits among peer trials
234 1297th of 2000 higher than 703 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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