Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

September 13, 2004

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Hunter SyndromeMucopolysaccharidosis II (MPS II)
Interventions
BIOLOGICAL

Idursulfase

Solution for intravenous infusion, 0.5 mg/kg once-weekly

Trial Locations (52)

12038

Ospedale S. S. Annunziata, Savigliano

13210

Upstate Medical University, State University of New York (SUNY), Syracuse

14186

Karolinska University Hospital, Stockholm

19104

Children's Hospital of Philadelphia, Philadelphia

20052

Universita Milano Bicocca / Ospedale S. Gerardo, Milan

20246

Universitatsklinikum Hamburg Eppendorf, Hamburg

23700

Servicio de Pediatria, Linares

27599

University of North Carolina at Chapel Hill, Chapel Hill

30165

Harbin Clinic, Rome

31076

Hospital Ducuing, Toulouse

35121

Universita di Padova, Padua

35385

Justus-Liebig Universitat, Giessen

40225

Universitatsklinik Dusseldorf Kinderklinik, Düsseldorf

41685

Drottning Silvias Barnsjukhus, Gothenberg

52242

University of Iowa Hospitals and Clinics, Iowa City

54601

Franciscan Skemp Healthcare, La Crosse

55101

Children's University Hospital Mainz AG, Mainz

61761

Mid-Illinois Hematology and Oncology Associates, Normal

63104

Saint Louis University Cardinal Glennon Children's Hospital, St Louis

67098

Hopital de Hautepierre, Strasbourg

68198

University of Nebraska Medical Center, Omaha

69003

Hopital Edouard Herriot, Lyon

77030

Baylor College of Medicine Texas Children's Hospital, Houston

80131

Universita degli Studi di Napoli Federico II, Napoli

80218

The Children's Hospital, Denver

84113

University of Utah Hospital, Salt Lake City

85013

St. Joseph's Hospital, Phoenix

89109

Comprehensive Cancer Centers of Nevada, Las Vegas

94609

Pediatric Clinical Research Center, Children's Hospital Oakland, Oakland

400370

Spitalul Clinic de Copii, Cluj-Napoca

02115

Children's Hospital Boston, Boston

57010-382

Fundacao Universidade de Ciencias da Saude de Alagoas Governador Lamenha Filho / UNCISAL, Maceió

47800-000

Clinica Casa de Saude Sao Joao, Barreiras

40110-060

c-HUPES/UFBA, Salvador

79008-900

Hospital Universitario da Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul, Campo Grande

21941-590

Instituto de Puericultura e Pediatria Martagao Gesteira / Hospital Pediatrico, Rio de Janeiro

90035-003

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

04023-062

UNIFESP Instituto de Oncologia Pediatrica, São Paulo

05403-000

Instituto da Crianca / Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

M5G 1XB

The Hospital for Sick Children Research Institute, Toronto

H3T 1C5

University of Montreal / Hopital Ste-Justine, Montreal

D-52074

Universitatsklinikum Aachen Kinderklinik, Aachen

D-37075

Universitatsklinikum Gottingen, Göttingen

08916

University Hospital Germans Trias i Pujol, Badalona

GU2 5XX

Royal Surrey County Hospital, Guildford

BA1 3QE

Bath and NE Somerset Primary Care Trust, Bath

CB2 2QQ

Addenbrooke's Hospital, Cambridge

DE22 3NE

Derbyshire Children's Hospital, Derby

G3 8SJ

Royal Hospital for Sick Children, Glasgow

WC1N3JH

Great Ormond Street Hospital for Sick Children, London

M27 4HA

Royal Manchester Children's Hospital, Manchester

NE1 4LP

Royal Victoria Infirmary, Newcastle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT00630747 - Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase | Biotech Hunter | Biotech Hunter