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NCT01150097 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
NCT01150097 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 284 participants.
The verdict
NCT01150097, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
Study Summary
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).
Interventions
- DRUG Tacrolimus (reduced tacrolimus)
- DRUG Everolimus (reduced tacrolimus)
- DRUG Tacrolimus (tacrolimus elimination)
- DRUG Everolimus (tacrolimus elimination)
- DRUG Tacrolimus (tacrolimus control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2010-03-31 |
| Est. Completion | 2013-05-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01150097
The ClinicalTrials.gov registry entry for NCT01150097 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus (reduced tacrolimus) is the first listed.
NCT01150097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01150097 about?
NCT01150097 is a clinical study titled "Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients". The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosi...
What is the current status of trial NCT01150097?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2010-03-31. Estimated completion is 2013-05-03.
What interventions are being tested in trial NCT01150097?
The interventions under investigation include: Tacrolimus (reduced tacrolimus) (DRUG), Everolimus (reduced tacrolimus) (DRUG), Tacrolimus (tacrolimus elimination) (DRUG), Everolimus (tacrolimus elimination) (DRUG), Tacrolimus (tacrolimus control) (DRUG).
Who is sponsoring clinical trial NCT01150097?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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