Trials / Completed
CompletedNCT02194985
Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Amicus Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | migalastat HCl 150 mg | Migalastat HCl 150 mg (equivalent to 123 mg migalastat) was provided as capsules in blister packs. One capsule was taken orally every other day. |
Timeline
- Start date
- 2015-03-14
- Primary completion
- 2019-10-23
- Completion
- 2019-10-23
- First posted
- 2014-07-21
- Last updated
- 2020-12-21
- Results posted
- 2020-12-21
Locations
28 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Egypt, France, Italy, Japan, Spain, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02194985. Inclusion in this directory is not an endorsement.