Trial record 1 of 1 for:
NCT00196716
A Study of the Safety and Efficacy of Fabrazyme in 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: NCT00196716 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Results First Posted : April 2, 2009
Last Update Posted : April 3, 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 | 21 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Fabrazyme |
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Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months. |
Period Title: 1.0 mg/kg Period | |
Started | 21 |
Completed | 21 |
Not Completed | 0 |
Period Title: 0.3 mg/kg Period | |
Started | 21 |
Completed | 21 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Fabrazyme | |
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Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months. | |
Overall Number of Baseline Participants | 21 | |
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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 | 21 participants | |
34.0 (10.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 21 participants | |
Female |
0 0.0%
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Male |
21 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
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Caucasian | Number Analyzed | 21 participants |
21 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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 MedInfo |
Organization: | Genzyme Corporation |
Phone: | 800-745-4447 |
EMail: | medinfo@genzyme.com |
Responsible Party: | Medical Monitor, Genzyme Corporation |
ClinicalTrials.gov Identifier: | NCT00196716 |
Other Study ID Numbers: |
AGAL-017-01 |
First Submitted: | September 12, 2005 |
First Posted: | September 20, 2005 |
Results First Submitted: | December 5, 2008 |
Results First Posted: | April 2, 2009 |
Last Update Posted: | April 3, 2015 |