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 - ND
- Conditions
- de novo liver transplant recipientsMedDRA version: 9.1Level: LLTClassification code 10024714Term: Liver transplant
- Registration Number
- EUCTR2007-001776-36-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
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
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 to 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% PLS SEE PROTOC.
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