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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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01128335 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01128335 record still lists
NCT01128335 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
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 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01128335's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 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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