Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
Information source: Protalix
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gaucher Disease
Intervention: plant expressed recombinant human glucocerebrosidase (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Protalix Official(s) and/or principal investigator(s):
Ari Zimran, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center, Jerusalem
Overall contact:
Raul Chertkoff, MD, Phone: +972-4-9889488, Email: raul@protalix.com
Summary
This is a multi-center, open-label, switchover trial to assess the safety of prGCD in 15
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 prGCD every two weeks for a
total of 20 IV infusions. The dose of prGCD will be equal to each patient's previous
imiglucerase dose. The infusions will be administered at the selected investigational site
(clinic/hospital) 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.
Clinical Details
Official title: 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
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Adverse events
Secondary outcome: Platelet count
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females, 18 years or older
- Female patients of child-bearing potential and male patients with female partners of
child-bearing potential must agree to use a medically acceptable method of
contraception, not including the rhythm method
- 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 unchanged) for at least the last six months
- Able to provide written informed consent
Exclusion Criteria:
- Currently taking another experimental drug for any condition
- Pregnant or nursing or planning to become pregnant
- History of allergy to carrots
- Presence of anti-glucocerebrosidase (GCD) antibodies
- 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 prGCD
- 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
Locations and Contacts
Raul Chertkoff, MD, Phone: +972-4-9889488, Email: raul@protalix.com
Shaare Zedek Medical Center, Jerusalem, Israel
Additional Information
Starting date: August 2008
Ending date: November 2009
Last updated: July 9, 2008
|
