drugset / Trial / NCT02904772
Alipogene Tiparvovec for the Treatment of LPLD Patients
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
Outcome
Outcome not reported
Stopped: “uniQure, has decided not to renew the Marketing Authorization of Glybera in the EU. This decision is not related to any safety, efficacy or quality issue”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |