EUCTR2009-017311-15-CZActive, not recruitingNot Applicable
Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentration-controlled everolimus in liver transplant recipients
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 470
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Ability and willingness to provide written informed consent before any assessment is performed;
- •2. Ability and willingness to adhere to study regimen;
- •3. Completed Month 24 visit of core study and continuously treated with assigned regimen.
- •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
- •1. Patients who have uncontrolled, severe hypercholesterolemia or hypertriglyceridemia;
- •2. Patients with platelet count <50,000/mm3;
- •3. Patients with an absolute neutrophil count of <1,000/mm³ or white blood cell count of <2,000/mm³;
- •4. Patients who have tested positive for human immunodeficiency virus (HIV);
- •5. Patients with clinically significant systemic infection requiring use of IV antibiotics;
- •6. Patients who are in a critical care setting requiring life support measures;
- •7. Use of prohibited medication;
- •8. Use of immunosuppressive agents or treatments not utilized in the protocol;
- •9. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes;
- •10. Pregnant or nursing (lactating) women;
- •11. Women of child-bearing potential not using highly effective methods of contraception
Investigators
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