Early vs.delayed EVERolimus in de novo HEART transplant recipients: optimozation of the safety/efficacy profile (EVERHEART Study) - EVERHEART

• Conditions: de novo heart transplant patients; MedDRA version: 9.1Level: HLGTClassification code 10028593Term: Myocardial disorders

• Registration Number: EUCTR2009-011008-43-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria: To be checked at screening: - male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation; - patients who have given written informed consent to participate in the study. To be checked at randomization: - GFR (by MDRD) ≥ 40 mL/min/1.73m2.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be checked at screening: - patients who are recipients of multiple solid organ transplants; - known hypersensitivity to rapamycin derivatives; - Known intolerance to cyclosporine or statins - patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive; - presence of Donor/Recipient serological mismatch for Hepatitis B or C; - recipients of organ from donors positive for Hepatitis B-surface antigen; - Panel Reactive Antibodies (cytotoxicity method) > 30%; - patients who are taking other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; - females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. To be checked at randomization - platelet count <40,000 /mm3 ; - WBC &#8804; 4.000/ mm3 ; - clinically significant systemic infection; - donor older than 60 years and/or with known donor heart disease at the time of transplant; - cold ischemia time > 6 hours; - patients unable to take oral medication; - patients who need treatment with drugs that are strong inducers or inhibitors of cytochrome P450 3A4

Study & Design

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