EUCTR2007-001776-36-IT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- de novo liver transplant recipients
- Sponsor
- OVARTIS FARMA
- Enrollment
- 320
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 to transplantation Serum creatinine of \&\#8805; 3\.0 mg/dL ( \&\#8805; 265 \&\#956;mol/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.
Outcomes
Primary Outcomes
Not specified
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