A randomized multicenter study evaluating efficacy, safety, tolerability and pharmacokinetics of AEB071 combined with tacrolimus or mycophenolate mofetil (MMF) vs. a tacrolimus-based control regimen in de novo liver transplant recipients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

•Ability and willingness to provide written informed consent and 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-positive and 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Recipient criteria
•Prior organ/cellular transplants or of multiple organ transplants
•Anti-HIV-positive. Laboratory results obtained within 6 months prior to transplantation are acceptable
•ABO incompatible allograft
•MELD-score > 35 within 1 month prior transplantation
•Serum creatinine of = 3.0 mg/dL ( = 265 µmol/L) or on renal replacement therapy > 1 week
Donor criteria:
•Donor age < 12 years
•Partial (split) liver allograft
•Living donor liver transplantation
•Cardiac death donors (DCD) / non-heartbeating donors
•HIV positive donors
•HCV positive donors into HCV negative recipients
•HBsAg positive donors
•Cold ischemic time of >15 hours
•Macrosteatosis > 50%
Medical history & concomitant disease criteria of recipient:
•Acute liver failure (UNOS I, T1)
•Hepatocellular carcinoma (HCC) that exceeds the Milan criteria (1 nodule =5 cm, 2-3 nodules all <3 cm) at the time of transplantation
•Past or present malignancy within the past 5 years (other than excised basal cell carcinoma 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 other than specified in the protocol (e.g. basiliximab allowed in only one of the study arms) 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 P450 3A4 system (see Protocol Appendix 2)
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 in at least two of the triplicate ECG-tracings at baseline (Fridericia correction), long QT-syndrome (own or with a family history) or with a family history of sudden unexplained cardiac death
•Patients with left branch bundle block (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 cur

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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