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NCT00813904 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
A Phase 4 study, sponsored by ZymoGenetics.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00813904: Completed Phase 4 study, sponsored by ZymoGenetics.
NCT00813904 is a Phase 4 study that has completed, run by ZymoGenetics. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00813904, a Phase 4 study, has completed, sponsored by ZymoGenetics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
Primary Outcome
Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.
Interventions
- BIOLOGICAL rThrombin, 1000 IU/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT00813904 record still lists
NCT00813904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which rThrombin, 1000 IU/mL is the first listed.
NCT00813904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00813904 about?
NCT00813904 is a clinical study titled "Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis". The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
What is the current status of trial NCT00813904?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2009-01. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00813904?
The interventions under investigation include: rThrombin, 1000 IU/mL (BIOLOGICAL).
Who is sponsoring clinical trial NCT00813904?
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 NCT00813904's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 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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