A 24-month clinical study to evaluate whether the drug everolimus in combination with the drug cyclosporine or the drug tacrolimus can be safely and effectively used in liver transplant patients from 1 month to less than 18 years.
- Conditions
- Paediatric liver transplant recipients with age equal/greater to 1 month and younger than 18 years.MedDRA version: 17.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-003069-14-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. A signed informed consent/assent must have been obtained from both parents or legal guardian(s) prior to patient participation in the study.
2. Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age.
3. Paediatric liver transplant recipients at the earliest 1 month and latest 6 month after liver transplantation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
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
1. Patients who experienced more than two episodes of tBPAR or who received T-cell depleting induction agents or acute rejection therapy.
2. Patients with hepato-biliary malignancies.
3. Patients transplanted due to fulminant hepatitis/acute liver failure.
4. Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins, portal vein or inferior vena cava at any time prior to the start of everolimus treatment (graft vessel patency by Doppler ultrasound confirmed and documented).
5. Patients with serum creatinine value >2 times age-related ULN at baseline or who received renal replacement therapy within one week prior to the start of everolimus treatment.
6. Patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion >500 mg/m2/24 hrs, at baseline.
7. Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant.
8. Patients who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg / dL; >5.6 mmol / L) at Baseline.
9. Patients with platelet count <35,000 mm3 and/or an absolute neutrophil count <1,000/mm3 or white blood cell count of <2,000/mm3 at Baseline.
10. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug.
11. Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
12. Patients with clinically significant systemic infection and/or in a critical care setting requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
13. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive ßHCG laboratory test (>9 mIU/mL) at Baseline.
14. Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree for abstinence from sexual activity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the evolution of renal function assessed by Glomerular Filtration Rate estimated by the Chronic Kidney Disease in Children (Schwartz) formula from start to Month 12 of an everolimus based regimen.;Secondary Objective: As per protocol:<br><br>--> Further efficacy objectives<br>--> Renal function related objectives<br>--> Development objectives<br>--> Safety objectives<br>--> Other objective;Primary end point(s): Title: Renal function<br><br>To evaluate the evolution of renal function assessed by Glomerular Filtration Rate.;Timepoint(s) of evaluation of this end point: At 12-month after start of study drug.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Rate of composite efficacy failure of tBPAR, GL or D.<br><br>Renal function over time.<br><br>AE/SAEs as per preferred term and SOC.<br><br>Evaluate incidence of treatment-related side effects.<br><br>Incidence and reason (e.g. AE) for premature discontinuation of study medication, and premature withdrawal from the study.<br><br>Incidence and reason (e.g. AE) for dose interruption and dose adjustment of study medication.;Timepoint(s) of evaluation of this end point: At 12-month and 24-month after start of everolimus based regimen<br><br>