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Aldurazyme

Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) Disease

Ensayo de Sanofi en Mucopolysaccharidosis I · Hurler Syndrome · Hurler-Scheie Syndrome · Scheie Syndrome (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

3

previstos

Centros

2

Fin del objetivo primario

oct 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2005.

Qué mide

Safety Evaluation (del registro, en inglés) (hasta 73 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multi-center, open label, study conducted to evaluate the safety of laronidase administered by intravenous drip infusion in Japanese patients with MPS I disease. Following baseline evaluation, patients will receive weekly infusions of JC0498 at an intravenous dose of 100 units/kg. Patient safety will be monitored continuously throughout the trial. In addition, the effects of JC0498 treatment in this patient population will be assessed by periodically evaluating aspects of MPS I disease in patients at scheduled intervals over the duration of the trial. Since patients may be eligible for the trial if they have received JC0498, a portion of the data may be captured retrospectively and recorded onto the case report forms (CRFs). This study represents the first good clinical practice (GCP) effort to characterize MPS I in the Japanese population and evaluate the effects of JC0498 on disease manifestations.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00258011), actualizada en feb 2014.