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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01598987
Other study ID # CRAD001H2305
Secondary ID 2011-003069-14
Status Completed
Phase Phase 3
First received March 1, 2012
Last updated November 29, 2016
Start date October 2012
Est. completion date June 2016

Study information

Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.


Description:

Study is active and ongoing but no longer recruiting since December 2014. The study Data Monitoring Committee meeting communicated to Novartis safety findings in the group of children younger than 7 years of age: high rate of premature discontinuation of study medication, high rate of post-transplant lymphoproliferative disease and high rate of related serious infections leading to hospitalization. In light of the safety findings, Novartis followed the DMC recommendation to discontinue the study medication in this age group and to stop enrolling new patients in this study (regardless of age).


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 17 Years
Eligibility Key Inclusion Criteria:

Signed informed consent from both parents or legal guardian(s) prior to patient participation in the study.

Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age.

Paediatric recipients at the earliest 1 month and latest 6 month after liver transplantation.

Key Exclusion Criteria:

Patients with hepato-biliary malignancies and/or patients transplanted due to fulminant hepatitis /acute liver failure.

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 study drug.

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 study drug and patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion >500 mg/m2/24 hrs, at Baseline.

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.

Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.

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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Immunosuppression after liver transplantation.

Locations

Country Name City State
Australia Novartis Investigative Site Parkville Victoria
Belgium Novartis Investigative Site Bruxelles
Canada Novartis Investigative Site Edmonton Alberta
Denmark Novartis Investigative Site København Ø
France Novartis Investigative Site Bron
Germany Novartis Investigative Site Bonn
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Tübingen
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Italy Novartis Investigative Site Bergamo BG
Italy Novartis Investigative Site Padova PD
Italy Novartis Investigative Site Roma ITA
Italy Novartis Investigative Site Torino TO
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Madrid
Sweden Novartis Investigative Site Stockholm
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site West Midlands Birmingham
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Madison Wisconsin
United States Novartis Investigative Site New Haven Connecticut
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site St Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Glomerular Filtration Rate Renal function assessed by estimated Glomerular Filtration Rate 12-month after start of study drug. At 12-month after start of study drug No
Secondary Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR), graft loss (GL) or death (D). Efficacy failure rate of tBPAR, GL, or D.at 12-month after start of study drug At 12-month after start of study drug No
Secondary Number of Adverse Events AE/SAEs as per preferred term and system organ class Incidence of treatment-related side effects Incidence and reason (e.g. AE) for premature discontinuation of study medication, and premature withdrawal from the study.
Incidence and reason (e.g. AE) for dose interruption and dose adjustment of study medication.
At 12-month and 24-month after start of study drug Yes
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