A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Protalix

Criteria

Inclusion Criteria:

• Successful completion of Protocol PB-06-002 or PB-06-005

• The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent

Exclusion Criteria:

• Currently taking another investigational drug for any condition.

• Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.

• 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.