|
|
|
|
|
|
Sponsored by: |
Genzyme |
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00701129 |
An exploratory, open-labeled study of patients with Infantile-Onset Pompe disease to evaluate the efficacy, clinical benefit and safety of prophylactic immunomodulatory regimen of Rituximab and Methotrexate prior to Myozyme infusion.
Condition | Intervention | Phase |
Pompe Disease (Late-Onset) Glycogen Storage Disease Type II |
Drug: Myozyme |
Phase IV |
Genetics Home Reference related topics: | Pompe disease |
Drug Information available for: | Alglucosidase Alfa |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-Naive CRIM (-) Patients With Infantile-Onset Pompe Disease |
Estimated Enrollment: | 5 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
1: Experimental |
Drug: Myozyme
IV infusion of 20 mg/kg; qow
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
United States, Massachusetts | |||||
Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient. | Recruiting | ||||
Cambridge, Massachusetts, United States |
Genzyme |
Study Director: | Medical Monitor | Genzyme Coorporation |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | AGLU03807 |
First Received: | June 17, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00701129 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|