A multicenter, double-blind, extension trial of two parallel dose groups of Plant cell expressed recombinant human glucocerebrosidase (prGCD) in patients with Gaucher disiease. - PB-06-003
- Conditions
- Gaucher Disease
- Registration Number
- EUCTR2008-005826-35-IT
- Lead Sponsor
- PROTALIX BIOTHERAPEUTICS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Completion of Protocol PB-06-001
The patient signs an informed consent
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
Currently taking another experimental drug for any condition
Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
Pregnant or nursing
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method