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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01128335 |
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Date of registration:
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20/05/2010 |
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Primary sponsor: |
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Public title:
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Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
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Scientific title:
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A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01128335 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Canada
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Czech Republic
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Finland
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France
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Germany
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Italy
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Spain
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Switzerland
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United States
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Contacts
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Name:
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Novartis Pharmceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Recipients of any race, 18 years or older
- Recipients of primary de novo orthotopic liver transplant from a deceased donor
Exclusion criteria:
- Prior organ/cellular transplant or multiple organ transplant
- MELD-score > 35
- HCC > Milan criteria
- Donor age < 12 years
- Cold ischemia > 15 hours
- Patients who are treated with drugs that are strong inducers or inhibitors of
cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Transplantation
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Intervention(s)
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Drug: MMF(1000mg bid) + tacrolimus + standard of care medications
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Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications
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Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
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Primary Outcome(s)
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Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade = 1, graft loss, or death) in the different treatment arms.
[Time Frame: Month 6]
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Secondary Outcome(s)
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Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).
[Time Frame: Months 3, 6, 12, and 24]
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Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade = 1, graft loss, or death) in the different treatment arms.
[Time Frame: Months 12, 24]
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Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade = 1 that is steroid-resistant
[Time Frame: Months 6, 12, 24]
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Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).
[Time Frame: Months 3, 6, 12, 24]
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Secondary ID(s)
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CAEB071B2201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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