Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 31, 2001

Primary Completion Date

March 31, 2005

Study Completion Date

March 31, 2005

Conditions
Mucopolysaccharidosis IHurler's SyndromeHurler-Scheie SyndromeScheie Syndrome
Interventions
BIOLOGICAL

Aldurazyme

Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks

BIOLOGICAL

Aldurazyme

0.58 mg/kg Aldurazyme every week for 208 weeks

BIOLOGICAL

placebo

Placebo for 26 weeks

Trial Locations (25)

14542

University of Rochester, Rochester

19104

The Childrens Hospital of Philadelphia, Philadelphia

22143

Children's Hospital Klinikum Nord Heidberg, Hamburg

27599

University of North Carolina at Chapel Hill, Chapel Hill

30322

Emory University School of Medicine, Atlanta

30625

Medizinishe Hochshule Hannover, Hanover

36604

University of South Alabama, Mobile

43606

Toledo Children's Hospital, Toledo

69120

Children's Hospital at the University Hospital of Heidelberg, Heidelberg

97601

Merle West Medical Center, Klamath Falls

02903

Rhode Island Hospital, Providence

88040-500

Hospital Universatario de Universidade Federal de Santa Catarina, Florianópolis

CEP 88025-301

Hospital Infantil Joana de Gusmao, Florianópolis

M5G 1X8

The Hospital for Sick Children, Toronto

T2T 5C7

Alberta Children's Hospital, Calgary

07740

Children's Hospital Klinikum der F.S. Universitat, Jena

00168

Catholic University Sacro Cuore, Rome

3000 GR

Academisch Ziekenhuis Rotterdam, Rotterdam

FY3 8NR

Blackpool Victoria Hospital, Blackpool

BT9 78A

Belfast City Hospital, Belfast

B4 6NH

Birmingham Children's Hospital, Birmingham

BS16 1LE

Bristol Royal Hospital for Children and Frenchay Hospital, Bristol

G11 6NT

Gartnavel Hospital, Glasgow

WC1N 3GH

Great Ormond Street Hospital for Sick Children and NHS Trust, London

NE1 4LB

Royal Victoria Hospital, Newcastle upon Tyne

All Listed Sponsors
collaborator

BioMarin/Genzyme LLC

INDUSTRY

lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00146770 - Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients | Biotech Hunter | Biotech Hunter