Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Protalix

ClinicalTrials.gov Identifier:

NCT00712348

First received: July 7, 2008

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2008

Last Updated Date

May 30, 2012

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00712348 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Platelet count [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Official Title ^ICMJE

A Phase 3 Multicenter, Open-label, Switchover Trial to Assess the Safety and Efficacy of Plant Cell Expressed Recombinant Human Glucocerebrosidase in Patients With Gaucher Disease Treated With Imiglucerase

Brief Summary

This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) ERT.

Detailed Description

This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) ERT. Eligible patients will enter a 12-week Stability Evaluation Period to establish the stability of their disease. Patients with stable disease will then be switched from their imiglucerase treatment to receive intravenous (IV) infusions of taliglucerase alfa every two weeks for a total of 20 IV infusions. The dose of taliglucerase alfa will be equal to each patient's previous imiglucerase dose. The infusions will be administered at the selected investigational site (clinic/hospital), infusion center, or at home. At the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gaucher Disease

Intervention ^ICMJE

Drug: Taliglucerase alfa

Intravenous infusion every 2 weeks

Other Name: Plant cell expressed recombinant glucocerebrosidase (prGCD)

Study Arm (s)

Experimental: Taliglucerase alfa

Open label taliglucerase alfa treatment

Intervention: Drug: Taliglucerase alfa

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females, 2 years or older
Confirmed diagnosis of Gaucher disease by the enzymatic activity assay
Stable Gaucher disease
Treatment with imiglucerase (Cerezyme®) for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least the last six months
Able to provide written informed consent

Exclusion Criteria:

Currently taking another experimental drug for any condition
History of allergy to carrots
History of allergy to beta lactam antibiotics
Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions
Presence of HIV and/or HBsAg and/or hepatitis C infection
Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency
Presence of any significant comorbidity that could confound the interpretation of the clinical response to taliglucerase alfa
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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Israel, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00712348

Other Study ID Numbers ^ICMJE

PB-06-002

Has Data Monitoring Committee

Yes

Responsible Party

Protalix

Study Sponsor ^ICMJE

Protalix

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ari Zimran, MD

Shaare Zedek Medical Center, Jerusalem

Information Provided By

Protalix

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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