Status:
COMPLETED
Assessing the Impact of Elelyso on Bone Involvement Currently Treated With Other ERTs
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Gaucher Disease, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to assess Elelyso treatment on bone disease in Gaucher patients currently treated with other enzyme replacement therapy. Experience from early access program (2009-2012...
Detailed Description
Open-label study in patients with Gaucher disease currently treated with commercial ERTs. Eligible patients will receive intravenous (IV) infusions of Elelyso every two weeks. The infusions will be ad...
Eligibility Criteria
Inclusion
- GD patients, male and female, 18 years or older
- Currently treated with enzyme replacement therapy for 5 years and more, with a stable unchanged dose in the previous 6 months
- Imaging features of significant residual bone disease defined as QCSI under 0.3 bone at risk
- Able to provide written informed consent
Exclusion
- Currently taking another experimental drug for any condition
- Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study.
- Past exposure to Elelyso
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04353466
Start Date
January 1 2017
End Date
July 31 2021
Last Update
October 28 2022
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