Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
Stopped early · Phase 2
Conditions studied: Fabry Disease
In brief
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
Key facts
- Study ID
- NCT00526071
- Run by
- Amicus Therapeutics
- People needed
- 23
- Starts
- 2007-09-17
- Expected to finish
- 2012-09-08
- Last updated by the study team
- 2018-10-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have completed another Phase 2 study of migalastat in Fabry Disease
- Women of childbearing potential must have had a negative result on their pregnancy test
- Male and female participants agreed to use a reliable method of contraception during study treatment and for 4 weeks after study treatment termination
- Were willing and able to provide written informed consent
You may not qualify if…
- Had not completed a Phase 2 study of migalastat in Fabry Disease
- Had a major protocol violation in the preceding migalastat trial and was discontinued
- Had undergone or was scheduled to undergo kidney transplantation or was currently on dialysis
- Had been treated with another investigational drug (except migalastat) within 30 days of study start
- Had been treated with Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), or Zavesca® (miglustat) within 2 weeks prior to enrollment
Where it is running
- Study site — Decatur, Georgia, United States
- Study site — New York, New York, United States
- Study site — Dallas, Texas, United States
- Study site — Parkville, Australia
- Study site — Porto Alegre, Brazil
- Study site — Garches, France
- Study site — London, United Kingdom
- Study site — Salford, United Kingdom
Full record on ClinicalTrials.gov
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