Trial record 1 of 1 for:
agal03204
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac 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: NCT00140621 |
Recruitment Status :
Completed
First Posted : September 1, 2005
Results First Posted : April 15, 2015
Last Update Posted : May 12, 2015
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Fabry Disease |
Intervention |
Drug: Agalsidase beta |
Enrollment | 6 |
Participant Flow
Recruitment Details | The study was conducted at 7 centers between July 06, 2005 and August 6, 2012. One participant was treated at 2 study sites because the participant had to be transferred to another site during the study. |
Pre-assignment Details |
Arm/Group Title | Agalsidase Beta (Fabrazyme [Recombinant Form]) |
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Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks. |
Period Title: Overall Study | |
Started | 6 |
Completed | 6 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Agalsidase Beta | |
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Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks. | |
Overall Number of Baseline Participants | 6 | |
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Efficacy evaluable population (EEP) included all registered participants except those who had serious deviations from protocol compliance requirements, did not receive study drug, had no data available at baseline or after study drug administration, and who were found to have no condition in cardiac Fabry disease.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 6 participants | |
53.8 (5.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
Female |
5 83.3%
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Male |
1 16.7%
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Weight
Mean (Standard Deviation) Unit of measure: Kilograms (kg) |
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Number Analyzed | 6 participants | |
58.50 (9.24) | ||
Height
Mean (Standard Deviation) Unit of measure: Centimeters (cm) |
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Number Analyzed | 6 participants | |
156.63 (7.20) | ||
Left Ventricular Hypertrophy
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 6 participants |
No | 0 | |
Yes | 6 | |
Globotriaosylceramide (GL-3) Accumulation in the Myocardium
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 6 participants |
No | 0 | |
Yes | 1 | |
Not Measured | 5 |
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.
Prior to publishing results from this study in academic meetings, medical journals, etc., the investigator and subinvestigator of the post-manufacturing/marketing clinical study must obtain the approval from the sponsor of the post-manufacturing/marketing clinical study in writing.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
EMail: | Contact-US@Sanofi.com |
Responsible Party: | Sanofi ( Genzyme, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00140621 |
Other Study ID Numbers: |
AGAL03204 |
First Submitted: | August 30, 2005 |
First Posted: | September 1, 2005 |
Results First Submitted: | April 1, 2015 |
Results First Posted: | April 15, 2015 |
Last Update Posted: | May 12, 2015 |