null - FindTrial

A Multicenter Extension Study of Taliglucerase alfa in Adult Subjects with Gaucher Disease - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003685-32-ES

Enrollment

Registered

2011-10-13

Start date

2012-01-27

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gaucher disease MedDRA version: 14.0 Level: PT Classification code 10018048 Term: Gaucher's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: recombinant human glucerebrosidase Product Code: Taliglucerase Alfa Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: Taliglucerase alfa CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects ?18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocol PB-06-001 and were enrolled in extension study PB-06-003.;Secondary Objective: NA;Primary end point(s): 1- The following efficacy variables will be assessed: - Spleen volume - Liver volume - Platelet count - Hemoglobin - Biomarkers (chitotriosidase or pulmonary and activation-regulated chemokine (PARC/CCL18) - DEXA 2- The safety of taliglucerase alfa will be assessed by the following: - Clinical laboratory - Echocardiography - Adverse events - Anti-taliglucerase alfa antibodies;Timepoint(s) of evaluation of this end point: NA	—

Measure

Time frame

Main Objective: To further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects ?18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocol PB-06-001 and were enrolled in extension study PB-06-003.;Secondary Objective: NA;Primary end point(s): 1- The following efficacy variables will be assessed: - Spleen volume - Liver volume - Platelet count - Hemoglobin - Biomarkers (chitotriosidase or pulmonary and activation-regulated chemokine (PARC/CCL18) - DEXA 2- The safety of taliglucerase alfa will be assessed by the following: - Clinical laboratory - Echocardiography - Adverse events - Anti-taliglucerase alfa antibodies;Timepoint(s) of evaluation of this end point: NA

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Canada, Chile, Israel, Italy, Mexico, Serbia, South Africa, Spain

Contacts

Public ContactRaul Chertkoff

Protalix Biotherapeutics

raul@protalix.com97249028100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026