Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01128335 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT01128335 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 200 participants.
The verdict
NCT01128335, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
Interventions
- DRUG MMF(1000mg bid) + tacrolimus + standard of care medications
- DRUG sotrastaurin (200mg bid) + tacrolimus + standard of care medications
- DRUG sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128335
The ClinicalTrials.gov registry entry for NCT01128335 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 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 3 interventions - of which MMF(1000mg bid) + tacrolimus + standard of care medications is the first listed.
NCT01128335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128335 about?
NCT01128335 is a clinical study titled "Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients". This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
What is the current status of trial NCT01128335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2010-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01128335?
The interventions under investigation include: MMF(1000mg bid) + tacrolimus + standard of care medications (DRUG), sotrastaurin (200mg bid) + tacrolimus + standard of care medications (DRUG), sotrastaurin (300 mg bid) + tacrolimus + standard of care medications (DRUG).
Who is sponsoring clinical trial NCT01128335?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.