| July 7, 2008 |
| November 24, 2009 |
| December 2008 |
| February 2010 (final data collection date for primary outcome measure) |
| Adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00712348 on ClinicalTrials.gov Archive Site |
| Platelet count [ Time Frame: Monthly ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase |
| 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 |
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. |
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. |
| Phase III |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Gaucher Disease |
| Drug: plant expressed recombinant human glucocerebrosidase (prGCD) |
| Experimental: Open label prGCD treatment |
| |
| |
| Recruiting |
| 15 |
| February 2010 |
| February 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Australia, Israel, Serbia, Spain, United Kingdom |
| |
| NCT00712348 |
| Einat Almon, Protalix Biotherapeutics |
| PB-06-002 |
| Protalix |
|
| Principal Investigator: |
Ari Zimran, MD |
Shaare Zedek Medical Center, Jerusalem |
|
|
| Protalix |
| November 2009 |
