EUCTR2007-005516-61-IT
Active, not recruiting
Not Applicable
Multicenter randomized study to assess the efficacy and the safety of two therapeutic regimens(high dose of imiglucerase versus co-administration of imiglucerase and miglustat) in type I Gaucher disease patients who have not responded to previous treatment with low dose imiglucerase - ND
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- GAUCHER disease
- Sponsor
- ISTITUTO GIANNINA GASLINI
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •confirmed diagnosis of gaucher disease with a documented deficiency of glucocerebrosidase by enzyme assay genotypic characterization minimum age 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •pregnancy evidence of medical emotional behavioural or psychological conditions which would interfere with the patient\`s compliance
Outcomes
Primary Outcomes
Not specified
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