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Sponsored by: |
Shire Human Genetic Therapies, Inc. |
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Information provided by: | Shire Human Genetic Therapies, Inc. |
ClinicalTrials.gov Identifier: | NCT00882921 |
The objective of this study is to evaluate the effect of anti-idursulfase IgG, IgM & IgE antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy.
Condition |
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Hunter Syndrome |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Multi-Center Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Enrolled in the Hunter Outcome Survey (HOS) Receiving Idursulfase Enzyme Replacement Therapy |
Blood and urine
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
This study is being conducted to satisfy post-marketing commitments to monitor anti-idursulfase antibody development in Hunter syndrome patients after long-term idursulfase enzyme replacement therapy. The study will be conducted as a sub-study within the Hunter Outcome Survey (HOS). Hunter syndrome patients in the HOS who have previously received idursulfase as well as treatment-naive patients who will begin idursulfase treatment within 30 days of study enrollment will be included.
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with Hunter syndrome
Inclusion Criteria:
Patients must meet all of the following criteria to be considered eligible for enrollment:
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for this study:
Contact: Tiffany Crump | 484-595-8850 | tcrump@shire.com |
United States, California | |
Children's Hospital & Research Center Oakland | Recruiting |
Oakland, California, United States, 94609 | |
Contact: Paul Richard Harmatz, MD 510-428-3885 pharmatz@mail.cho.org | |
Contact: Jo Ann Johnson 510-428-3885 ext 5421 jajohnson@mail.cho.org | |
Principal Investigator: Paul R Harmatz, MD |
Principal Investigator: | Paul R Harmatz, MD | Children's Hospital & Research Center Oakland |
Responsible Party: | Shire Human Genetic Therapies, Inc. ( David AH Whiteman, MD Principal Medical Director ) |
Study ID Numbers: | HGT-ELA-042 |
Study First Received: | April 16, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00882921 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hunter syndrome hunters syndrome hunter's syndrome hunter disease hunters disease hunter's disease MPS II MPSII MPS2 MPS 2 mps 2 mps ii mucopolysaccharides lysosomal storage disease lysosomal storage disorder |
chronic ear infection enlarged adenoids mps symptoms mps diagnosis mps ii therapy MPS II therapy MPS II treatment ert treatment elaprase idursulfase iduronate sulfatase iduronate 2 sulfatase enzyme replacement therapy hunter syndrome treatment hunter's syndrome treatment |
Mucopolysaccharidosis II Metabolic Diseases Lysosomal Storage Diseases Mucopolysaccharidosis Type II Mental Retardation Metabolism, Inborn Errors Antibodies Mucopolysaccharidoses Heredodegenerative Disorders, Nervous System |
Genetic Diseases, Inborn Genetic Diseases, X-Linked Connective Tissue Diseases Neurologic Manifestations Metabolic Disorder Neurobehavioral Manifestations Immunoglobulins Hunter-McAlpine Syndrome |
Mucopolysaccharidosis II Disease Metabolic Diseases Lysosomal Storage Diseases Nervous System Diseases Mucinoses Mental Retardation Metabolism, Inborn Errors Mucopolysaccharidoses Pathologic Processes |
Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Syndrome Connective Tissue Diseases Genetic Diseases, X-Linked Neurologic Manifestations Mental Retardation, X-Linked Neurobehavioral Manifestations Carbohydrate Metabolism, Inborn Errors |