Genzyme Rare disease registries (Gaucher Disease Registry Protocol).

Sanofi Synthelabo India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.all age group from new born to old age allowed
•2. All patients with a confirmed diagnosis of Gaucher disease who are willing and able to provide written informed consent and any additional authorization documents required by local law to send health information to the Registry, Regardless of whether they are receiving disease therapy including ERT (such as imiglucerase) and irrespective of the commercial product with which they are being treated.
•3. A confirmed diagnosis is defined as a documented acid Ã?-glucosidase deficiency and/or mutations in the acid Ã?-glucosidase gene.

•1. There are no exclusion criteria in this Registry. Patients are allowed to participate in clinical studies and may be receiving different therapies to treat their disease. However, data entry (with the exception of data collected prior to the patientâ??s participation in the clinical study) should be put on hold in the Registry during the patientsâ?? participation in the clinical study. When the patient has discontinued or completed the clinical study, data entry can resume. Where the clinical study was sponsored by Genzyme, the Registry team may work with
•participating physicians, as necessary and appropriate, to facilitate the entry of data from the clinical study (to the extent such data are also collected by the Registry) into the Registry database.

发起方

Sanofi Synthelabo India Private Limited