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

Gaucher Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422187
• Other study ID #: PB-06-007
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gaucher Disease

Intervention

Drug:
• Taliglucerase alfa
Taliglucerase infusion every two weeks for 21 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spleen Volume	Spleen volume measured by MRI	60 months
Secondary	Liver Volume	Liver volume by MRI	60 months
Secondary	Platelet Count	Platelet count measure annually	60 months
Secondary	Hemoglobin	Hemoglobin measure yearly	60 months