A

Phase 1

• Conditions: Gaucher disease; MedDRA version: 14.0Level: PTClassification code 10018048Term: Gaucher's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-003676-37-ES
• Lead Sponsor: Protalix Biotherapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-14
• Study Completion: 2013-07-07
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Successful completion of Protocol PB-06-002 or PB-06-005.
2. The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) no
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

1. Subjects currently taking another investigational drug for any condition.
2. The presence of neurological signs and symptoms characteristic of Gaucher disease
with complex neuronopathic features other than longstanding oculomotor gaze palsy.
3. The presence of a medical, emotional, behavioral or psychological condition that, in
the judgment of the Investigator, would interfere with the subject?s compliance with
the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified