CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5 enrolled
Drug / intervention
Alipogene Tiparvovec (AMT-011), Human LPL [S447X] +3 moregenetic
Likely dose
mycophenolate mofetil 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00891306
NCT00891306Phase 3Completed
CompareCT.gov

An Open-label Study to Assess the Efficacy and Safety of Alipogene Tiparvovec (AMT-011), Human LPL [S447X], Expressed by an Adeno-Associated Viral Vector After Intramuscular Administration in LPL-deficient Adult Subjects

Amsterdam Molecular Therapeutics·interventional·Posted May 1, 2009·Updated Sep 29, 2011

In Brief

A Phase 3 clinical trial evaluating Alipogene Tiparvovec (AMT-011), Human LPL [S447X], mycophenolate mofetil, and 2 other interventions for Familial Lipoprotein Lipase Deficiency. Completed, enrolled 5 participants across 2 sites.

Detailed Summary

This trial is designed to expand the currently available data on the safety and efficacy of alipogene tiparvovec treatment in lipoprotein lipase deficiency (LPLD) and to further the understanding of possible mechanisms of action of the therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Lipoprotein Lipase Deficiency
CountriesCanada
CollaboratorsThe Clinical Trial Company

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2009
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.2 years ago

Interventions

Alipogene Tiparvovec (AMT-011), Human LPL [S447X]genetic

intra muscular, 1 x E12 gc per kg body weight, injected in a single series of intramuscular injections

mycophenolate mofetildrug

oral, 2 g/day, day -3 till week 12

cyclosporinedrug

oral, 3 mg/kg/day, day -3 till week 12

methylprednisolonedrug

single intravenous bolus of methylprednisolone (1 mg/kg bodyweight)