Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

Plain-language summary

This was an extension study evaluating longer-term use of the enzyme therapy Taliglucerase alfa in the treatment of Gaucher disease. It was open to patients who had successfully completed the earlier PB-06-001 protocol. Sponsored by Pfizer, the study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Pfizer

Intervention

Taliglucerase alfa

Start date

6/1/2008

Estimated completion

8/1/2013

Countries

United States, Australia, Canada, Chile, Israel, South Africa, Spain, United Kingdom

Related genes

Locations

• Decatur, United States
• New York, United States
• Parkville, Australia
• Toronto, Canada
• Santiago, Chile
• Haifa, Israel
• Jerusalem, Israel
• Morningside, South Africa
• Zaragoza, Spain
• Cambridge, United Kingdom
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Successful completion of Protocol PB-06-001
* The patient signs informed consent

Exclusion Criteria:

* Currently taking another experimental drug for any condition
* Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
* Pregnant or nursing
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study