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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.

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

Details

• Lead Sponsor: Pfizer; Protalix

Criteria

Inclusion Criteria:

• Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003

• The subject signs an informed consent

Exclusion Criteria:

• Currently taking another investigational drug for any condition.

• 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.