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NCT00118742 · ClinicalTrials.gov registry record · Phase 4
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 293
- Enrollment target
NCT00118742 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 293 participants.
The verdict
NCT00118742, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 293 participants
- Enrollment target
Study Summary
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Cyclosporine
- DRUG mycophenolate mofetil [CellCept]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00118742
The ClinicalTrials.gov registry entry for NCT00118742 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 293 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00118742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00118742 about?
NCT00118742 is a clinical study titled "Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant". This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclospor...
What is the current status of trial NCT00118742?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 293 participants. The study started on 2005-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00118742?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG), mycophenolate mofetil [CellCept] (DRUG).
Who is sponsoring clinical trial NCT00118742?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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