Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

September 18, 2003

Primary Completion Date

March 16, 2005

Study Completion Date

March 16, 2005

Conditions
Mucopolysaccharidosis II
Interventions
BIOLOGICAL

Iduronate-2-sulfatase enzyme replacement therapy

Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.

BIOLOGICAL

iduronate-2-sulfatase enzyme replacement therapy

Patients will receive every other week infusions of idursulfase at a dose of 0.5 mg/kg.

BIOLOGICAL

Placebo

Patients will receive weekly infusions of placebo.

Trial Locations (9)

27599

University of North Carolina at Chapel Hill, Chapel Hill

63110

St. Louis Children's Hospital, Washington University, St Louis

77030

Texas Children's Hospital, Baylor College of Medicine, Houston

94609

Children's Hospital Oakland, Oakland

Unknown

Hospital de Clinicas de Porto Alegre, Porto Alegre

Children's Hospital, Johannes-Gutenburg Universitaet Mainz, Mainz

CB2 2QQ

Addenbrooke's Hospital, Cambridge

WC1N3JH

Great Ormond Street Hospital for Sick Children, London

M27 4HA

Royal Manchester Children's Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY