CTRI/2018/03/012357
Recruiting
未知
Genzyme Rare disease registries (Gaucher Disease Registry Protocol).
Sanofi Synthelabo India Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Gaucher DiseaseHealth Condition 2: E752- Other sphingolipidosis
- Sponsor
- Sanofi Synthelabo India Private Limited
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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