drugset / Trial / NCT02904772

Alipogene Tiparvovec for the Treatment of LPLD Patients

NCT02904772

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the study is to provide further confirmatory evidence of clinical benefit in LPLD patients treated with alipogene tiparvovec by assessing both the "clinical response" (as defined by a range of parameters), and "the metabolic response" (postprandial CM metabolism) in LPLD patients with and without an immunosuppressant regimen.

Timeline

Start
2016-10
Primary completion
2020-06
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alipogene Tiparvovec Unknown 1e+12 unknown Intramuscular
Subject Cyclosporine Peptide 3 mg/kg
Subject Mycophenolate Mofetil Small molecule 1 g
Background Prednisolone Other / unclassified 1 mg/kg Intravenous