Trial record 1 of 1 for:
NCT00074958
A Study of Fabrazyme in Pediatric Patients With Fabry Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00074958 |
Recruitment Status :
Completed
First Posted : December 25, 2003
Results First Posted : June 16, 2009
Last Update Posted : April 2, 2015
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Sponsor:
Genzyme, a Sanofi Company
Information provided by:
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Fabry Disease |
Intervention |
Biological: Fabrazyme (agalsidase beta) |
Enrollment | 16 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Fabrazyme |
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1.0 mg/kg of Fabrazyme given to the patients every 2 weeks. |
Period Title: Overall Study | |
Started | 16 |
Completed | 15 |
Not Completed | 1 |
Reason Not Completed | |
Adverse Event | 1 |
Baseline Characteristics
Arm/Group Title | Fabrazyme | |
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1.0 mg/kg of Fabrazyme given to the patients every 2 weeks. | |
Overall Number of Baseline Participants | 16 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 16 participants | |
12.1 (2.52) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | |
Female |
2 12.5%
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Male |
14 87.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
The trial was not powered to demonstrate clinical benefit.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: | Genzyme Medical Information |
Organization: | Genzyme Corporation |
Phone: | 800-745-4447 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medical Monitor, Genzyme Corporation |
ClinicalTrials.gov Identifier: | NCT00074958 |
Other Study ID Numbers: |
AGAL-016-01 |
First Submitted: | December 24, 2003 |
First Posted: | December 25, 2003 |
Results First Submitted: | March 3, 2009 |
Results First Posted: | June 16, 2009 |
Last Update Posted: | April 2, 2015 |