What this study is
The Gaucher Outcomes Survey (GOS) is an ongoing observational, international, multi-center, long-term Registry of Patients with Gaucher Disease irrespective of their treatment status or type of treatment received. No experimental intervention is involved. Patients undergo clinical assessments and receive care as determined by the patients' treating physician.
The objectives of the registry include to evaluate the safety and long-term effectiveness of velaglucerase alfa, to characterize patients receiving velaglucerase alfa or other Gaucher Disease-specific treatments, to gain a better understanding of the natural history of GD and to serve as a database for evidence-based management of Gaucher Disease over time in real-life clinical practice.
Study details
- Sponsor
- Shire
- Conditions
- Gaucher Disease
- Enrolling
- 1,257 people
- Starts
- 2010-12-29
- Est. completion
- 2028-09-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients of any age or gender with confirmed diagnosis (biochemical and/or genetic) of Gaucher disease
- Signed and dated written informed consent from the patient or, for patients aged <18 years (<16 years in the United Kingdom [UK]), their parent and/or legally authorized representatives (LAR), and assent of the minor where applicable. Legally authorized representatives are also applicable for cognitively impaired patients.
You can't join if
- Patients currently enrolled in ongoing blinded clinical trials (drugs or devices; includes all blinded trials)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCentral Contact
Lexington, Massachusetts, United States
- Shire Central Contact · ContactClinicalTransparency@shire.com
- Central Contact · Principal investigator
Recruiting
Study team
Sponsor
Shire
Study ID GOS
Study director
Shire Study Physician
Shire
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.