Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled everolimus in liver transplant recipients - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 470

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following 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 being 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

Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Patients who have uncontrolled, severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) at the evaluation before enrolment into the extension (to be confirmed at Month 24). 2. Patients with platelet count <50,000/mm3 at the evaluation before enrolment into the extension (to be confirmed at Month 24). 3. Patients with an absolute neutrophil count of <1,000/mm? or white blood cell count of <2,000/mm? at the evaluation before enrolment into the extension (to be confirmed at Month 24) Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Patients who have uncontrolled, severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) at the evaluation before enrolment into the extension (to be confirmed at Month 24). 2. Patients with platelet count <50,000/mm3 at the evaluation before enrolment into the extension (to be confirmed at Month 24). 3. Patients with an absolute neutrophil count of <1,000/mm? or white blood cell count of <2,000/mm? at the evaluation before enrolment into the extension (to be confirmed at Month 24) 4. Patients who have tested positive for human immunodeficiency virus (HIV). 5. Patients with clinically significant systemic infection requiring active use of IV antibiotics at Month 24. 6. Patients who are in a critical care setting at Month 24 requiring life support measures such as mechanical ventilation, dialysis, requirement of vasopressor agents. 7. Use of medication that is prohibited by the study protocol at Month 24. 8. Use of immunosuppressive agents or treatments at Month 24 that are 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, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive BHCG laboratory test (> 5 mIU/mL) 11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS a. their career, lifestyle, or sexual orientation precludes intercourse with a male partner, or b. their partners have been sterilized by vasectomy or other means, or c. they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); not highly effective are e.g. single-barrier methods, combination of female barrier method with spermicidal gel, periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal. Reliable contraception should be maintained throughout the study and for 8 weeks after study drug discontinuation. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In case of oophorectomy alone, only when

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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