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: prophylaxis of liver allograft rejection in liver transplant recipients; MedDRA version: 13.1Level: LLTClassification code 10066543Term: Acute allograft rejectionSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2009-017311-15-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-20
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1. Ability and willingness to provide written informed consent before any extension specific 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified