Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
NCT00712348
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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
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| 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®) enzyme replacement therapy. | ||
| 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 ICMJE | Phase 3 | ||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (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 Arms ICMJE | Experimental: Taliglucerase alfa
Open label taliglucerase alfa treatment Intervention: Drug: Taliglucerase alfa | ||
| Publications * | Pastores GM, Petakov M, Giraldo P, Rosenbaum H, Szer J, Deegan PB, Amato DJ, Mengel E, Tan ES, Chertkoff R, Brill-Almon E, Zimran A. A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase. Blood Cells Mol Dis. 2014 Dec;53(4):253-60. doi: 10.1016/j.bcmd.2014.05.004. Epub 2014 Jun 18. | ||
* 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 | Completed | ||
| Actual Enrollment ICMJE | 31 | ||
| Original Estimated Enrollment ICMJE | 15 | ||
| Actual Study Completion Date ICMJE | May 2013 | ||
| Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Australia, Canada, Israel, Spain, United Kingdom, United States | ||
| Removed Location Countries | Serbia | ||
| Administrative Information | |||
| NCT Number ICMJE | NCT00712348 | ||
| Other Study ID Numbers ICMJE | PB-06-002 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Pfizer | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | September 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||