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Clinical Trials/EUCTR2007-001776-36-GB
EUCTR2007-001776-36-GB
Active, not recruiting
Phase 1

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.

ovartis Pharma Services AG0 sites0 target enrollmentApril 27, 2009
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DrugsPrograf 0.5mg hard capsulesCellcept 250mg capsulesSIMULECT 10mg powder and solvent for solution for injection or infusionPrograf 1 mg hard capsulesPrograf 5 mg hard capsules

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma Services AG
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 27, 2009
End Date
March 12, 2012
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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 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

Outcomes

Primary Outcomes

Not specified

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