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NCT00224406 · ClinicalTrials.gov registry record · Phase 2
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT00224406: Completed Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT00224406 is a Phase 2 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00224406, a Phase 2 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients. The safety of repertaxin in the specific clinical setting was also evaluated. The ability of repertaxin to reduce target cells (polymorphonuclear leukocyte \[PMN\]) infiltration into the graft was evaluated to confirm its mechanism of action.
Primary Outcome
The PaO2/FiO2 ratio was calculated to assess the severity of hypoxemia, or low blood oxygen levels. A low PaO2/FiO2 value has been associated with increased mortality and hospital stay in patients admitted to the intensive care unit (ICU). It was calculated by dividing the partial pressure of oxygen in arterial blood (PaO2) by the fraction of inspired oxygen (FiO2). A normal P/F ratio was typically above 300, and a lower ratio indicates a greater severity of hypoxemia. As the Pa02/Fi02 ratio was
Interventions
- OTHER Placebo
- DRUG Repertaxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2005-05-01 |
| Est. Completion | 2007-09-13 |
| Phase | Phase 2 |
What the finished NCT00224406 record still lists
NCT00224406 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00224406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00224406 about?
NCT00224406 is a clinical study titled "Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation". The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients. The safet...
What is the current status of trial NCT00224406?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2005-05-01. Estimated completion is 2007-09-13.
What interventions are being tested in trial NCT00224406?
The interventions under investigation include: Placebo (OTHER), Repertaxin (DRUG).
Who is sponsoring clinical trial NCT00224406?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00224406's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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