EUCTR2007-001776-36-CZActive, not recruitingNot Applicable
A 24-month randomized, multicenter study, evaluating efficacy, safety, tolerability and pharmacokinetics of sotrastaurin (STN) combined with tacrolimus (TAC) vs a tacrolimus / mycophenolate mofetil (MMF) - based control regimen in de novo liver transplant recipients - B2201
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patient provided written informed consent and is considered willing and able to adhere to study regimen
- •Male and female patients of any race, 18 years or older
- •De novo recipients of a primary orthotopic liver transplant from a deceased donor
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 121
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
Exclusion Criteria
- •Recipient criteria
- •Prior organ/cellular transplants or of multiple organ transplants
- •Anti-HIV-positive. Lab results obtained within 6 months prior to Tx are
- •AB0 incompatible allograft
- •MELD-score > 35 within 1 month prior to Tx
- •Serum creatinine = 3.0 mg/dL or on renal replacement therapy > 1 week
- •Donor criteria
- •Donor age < 12 years
- •Partial (split liver allograft Living donor liver transplantation)
- •Cardiac death donors / non-heartbeating donors
- •HIV positive donors
- •HBsAg positive donors
- •Cold ischemic time of >15 hours
- •Macrosteatosis > 50%
- •Medical history & concomitant disease criteria of the recipient
- •Acute liver failure (UNOS I, T1)
- •HCC that does exceed the Milan criteria (1 nodule =5 cm, 2-3 nodules all <3 cm) at time of Tx
- •Past or present malignancy within the past 5 years (other than excised BCC and
- •HCC satisfying the Milan criteria
- •Patients in whom biopsy cannot be safely performed (e.g. coagulopathy without the option of transjugular biopsy)
- •Severe active infection considered by the investigator to be unsafe for the study
- •(Co-)medication related criteria
- •Patients with antibody induction therapy or who receive any other immunosuppressive therapy not defined in the protocol
- •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •Patients who are requiring the administration of strongly interacting drugs of the cytochrome P4503A4 system
- •Cardiac safety criteria
- •Patients requiring drugs with QT-prolonging properties (e.g. antiarrhythmic drugs, such as amiodarone, sotalol, dofetilide, quinidine, procainamide, disopyramide)
- •Patients with QTc > 470 msec (females) and > 450 msec (males), respectively, at screening or at baseline (Fridericia correction), patients with long QT-syndrome (own or with a family history) or with a family history of sudden unexplained cardiac death
- •Patients with LBBB or who experienced, during the previous 6 months, hospitalization for heart failure of cardiac etiology, or significant and persistent left-ventricular dysfunction (LVEF < 40%)
- •Patients with a history, in the preceding 3 months, of significant and persistent arrhythmias such as ventricular fibrillation or tachycardia, or atrial fibrillation or flutter
- •Patients with symptomatic coronary artery disease
- •General criteria
- •Existence of any surgical, medical or mental conditions, other than the current transplantation, which, in the opinion of the investigator, might interfere with the objectives of the study
- •Pregnant or nursing (lactating) women
- •WOCBP not practicing reliable methods of contraception
- •No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients
Investigators
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