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NCT00859547 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
A Phase 4 study, sponsored by ZymoGenetics.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00859547: Completed Phase 4 study, sponsored by ZymoGenetics.
NCT00859547 is a Phase 4 study that has completed, run by ZymoGenetics. The registered enrollment target is 30 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
NCT00859547, a Phase 4 study, has completed, sponsored by ZymoGenetics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
Primary Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly rela
Interventions
- BIOLOGICAL rThrombin, 1000 IU/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
What the finished NCT00859547 record still lists
NCT00859547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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.
NCT00859547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00859547 about?
NCT00859547 is a clinical study titled "Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants". The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
What is the current status of trial NCT00859547?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2009-03. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00859547?
The interventions under investigation include: rThrombin, 1000 IU/mL (BIOLOGICAL).
Who is sponsoring clinical trial NCT00859547?
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 NCT00859547's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 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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