NCT01109498 - Safety and Efficacy in LPL-Deficient Subjects of AMT-011, an Adeno-Associated Viral Vector Expressing Human Lipoprotein Lipase [S447X] | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

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

GENETIC

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

intra muscular, 3 x E11 gc per kg body weight, injected in a single series of intramuscular injections

DRUG

cyclosporine

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

Trial Locations (1)

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