NCT00891306 - Efficacy and Safety of Human Lipoprotein Lipase (LPL)[S447X] Expressed by an Adeno-Associated Viral Vector in LPL-deficient Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

April 30, 2011

Conditions

Familial Lipoprotein Lipase Deficiency

Interventions

GENETIC

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

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

DRUG

mycophenolate mofetil

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

DRUG

cyclosporine

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

DRUG

methylprednisolone

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

Trial Locations (2)

ECOGENE-21 Clinical Trial Center / Centre de santé et de services sociaux de Chicoutimi, Chicoutimi

Centre des Maladies Lipidiques de Québec, Québec