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NCT00048165 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 434
- Enrollment target
NCT00048165: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00048165 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 434 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048165, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 434 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.
Primary Outcome
The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment fail
Interventions
- DRUG Placebo
- DRUG Methylprednisolone
- DRUG Mycophenolate mofetil
- DRUG cyclosporine
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 1999-08 |
| Est. Completion | 2002-08 |
| Phase | Phase 4 |
What the finished NCT00048165 record still lists
NCT00048165 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00048165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048165 about?
NCT00048165 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation". The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.
What is the current status of trial NCT00048165?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 434 participants. The study started on 1999-08. Estimated completion is 2002-08.
What interventions are being tested in trial NCT00048165?
The interventions under investigation include: Placebo (DRUG), Methylprednisolone (DRUG), Mycophenolate mofetil (DRUG), cyclosporine (DRUG), Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00048165?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00048165's enrollment target sits among peer trials
434 192nd of 2000 higher than 1,808 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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