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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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

HCV-negative recipients
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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
acceptable

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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