Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 8, 2011

Study Completion Date

July 8, 2011

Conditions
Hunter SyndromeMucopolysaccharidosis IIMPS II
Interventions
BIOLOGICAL

Idursulfase

Solution for intravenous infusion, 0.5 mg/kg weekly

Trial Locations (3)

10016

National Taiwan University Hospital, Dept. of Pediatrics and Medical Genetics, Taipei

90035-903

Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica, Porto Alegre

04-730

Instytut Pomnik Centrum Zdrowia Dziecka, Klinika Chorob Metaboliczynch, Endokrynologii i Diabetologii, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Covance

INDUSTRY

collaborator

PharmaNet

INDUSTRY

collaborator

PRA Health Sciences

INDUSTRY

lead

Shire

INDUSTRY

NCT00607386 - Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy | Biotech Hunter | Biotech Hunter