Treatment Protocol of Replagal for Patients With Fabry Disease
NCT ID: NCT01031173
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Patients diagnosed with Fabry disease who have not previously received treatment, who have received agalsidase beta, or who had previously received Replagal will be eligible to enroll in the study and will receive Replagal at a dose of 0.2 mg/kg body weight administered by an IV infusion over 40 minutes every other week.
This study will be conducted in the United States.
Study visits will occur in 3 phases:
* Screening/Baseline Phase: A Screening/Baseline period (Day -30 to Day -1) to determine eligibility and obtain baseline measurements. Patients who have previously received agalsidase beta will be tested for the presence of anti-agalsidase beta antibodies.
* Treatment Phase: A 12-month treatment phase during which all patients will receive Replagal administered IV every other week. Clinical assessments will occur at Months 1, 3, 6, 9, and 12. The study may be extended to continue giving patients access to treatment.
* End-of-Study Phase: An end-of-study contact either as an office visit or follow-up telephone call will occur one month after the last infusion.
Conditions
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Interventions
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agalsidase alfa
0.2 mg/kg body weight, administered by an intravenous infusion over 40 minutes, every other week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to provide written informed consent, and assent if applicable.
3. Females of childbearing potential must agree to use a method of birth control throughout the study and for at least 30 days after the final infusion. The method of contraception must be considered adequate and appropriate in the opinion of the investigator.
Exclusion Criteria
2. The patient is pregnant or breast feeding.
3. Concomitant use of agalsidase beta (Fabrazyme).
4. Has received treatment with any investigation drug or device within the 30 days prior to study entry.
5. Otherwise unsuitable for the study, in the opinion of the Investigator.
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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AKDHC Tucson Campbell
Tucson, Arizona, United States
University of California San Diego Medical Center
La Jolla, California, United States
Kaiser Medical Group Southern CA, Regional Metabolic Services
Los Angeles, California, United States
Children's Hospital & Research Center Oakland
Oakland, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
Central Coast Nephrology
Salinas, California, United States
Denver Nephrologists, PC
Denver, Colorado, United States
University Research Foundation for Lysosomal Storage Disorders
Coral Springs, Florida, United States
Stuart Oncology Associates
Stuart, Florida, United States
Emory University School of Medicine
Decatur, Georgia, United States
Emory University
Decatur, Georgia, United States
University of Iowa Health Center
Iowa City, Iowa, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Infusion Associates
Grand Rapids, Michigan, United States
University of Missouri Healthcare
Columbia, Missouri, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
North Shore Hematology/Oncology
Manhasset, New York, United States
New York University School of Medicine
New York, New York, United States
Fullerton Genetics Center-Mission, St. Joseph's Hospital
Asheville, North Carolina, United States
The Toledo Hospital
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Baylor University Medical Center
Dallas, Texas, United States
Tidewater Kidney Specialists
Chesapeake, Virginia, United States
Carilion New River Valley Medical Center
Christiansburg, Virginia, United States
O & O Alpan LLC
Springfield, Virginia, United States
Countries
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Other Identifiers
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HGT-REP-059
Identifier Type: -
Identifier Source: org_study_id
NCT00726089
Identifier Type: -
Identifier Source: nct_alias
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