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: EUCTR2011-003685-32-ES
• Lead Sponsor: Protalix Biotherapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-13
• Study Completion: 2013-07-08
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Eligible subjects must fulfill the following inclusion criteria:
1. Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
2. The subject 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 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Eligible subjects may not have any of the following exclusion criteria:
1. Currently taking another investigational drug for any condition.
2. Presence of any 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