Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

February 20, 2008

Primary Completion Date

October 22, 2010

Study Completion Date

October 22, 2010

Conditions
Late Infantile Metachromatic Leukodystrophy
Interventions
DRUG

HGT-1111

Patients currently dosed with 100 U/kg or 200 U/kg will continue this treatment. Patients dosed with 50 U/kg will be equally randomized to treatment on 100 U/kg or 200 U/kg. The dose will be adjusted every 6-week to account for changes in body weight.The infusion length will be dependent on the dose. Infusion of 100 U/kg will be diluted in 50 ml isotonic sodium chloride and infused over 30 minutes. Infusion of 200 U/kg will be administered in the same manner except for an infusion time of 60 minutes.

Trial Locations (1)

2100

Rigshospitalet, Copenhagen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY