Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
NCT00526071 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2018-10-03
Summary
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
Conditions
Interventions
- DRUG
-
migalastat HCl
Sponsors & Collaborators
-
Amicus Therapeutics
lead INDUSTRY
Principal Investigators
-
Medical Monitor, Clinical Research · Amicus Therapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-17
- Primary Completion
- 2012-09-08
- Completion
- 2012-09-08
Countries
- United States
- Australia
- Brazil
- France
- United Kingdom
Study Locations
More Related Trials
-
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
NCT00925301 ·Status: COMPLETED ·Phase: PHASE3
-
Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
NCT01196871 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease
NCT02194985 ·Status: COMPLETED ·Phase: PHASE3
-
Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease
NCT01476163 ·Status: AVAILABLE
-
Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease
NCT04049760 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Patients With Fabry Disease (US Specific)
NCT06906367 ·Status: RECRUITING
-
Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease
NCT01218659 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants
NCT06904261 ·Status: RECRUITING ·Phase: PHASE3
-
German Observational Multicenter Study of Patients With Fabry Disease Under Chaperone Therapy With Migalastat-HCl.
NCT03135197 ·Status: COMPLETED
-
Study to Collect Data on Fabry Disease Patients With Enhanceable Alpha-Galactosidase A Activity
NCT00106912 ·Status: COMPLETED
-
A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects
NCT01853852 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101
NCT00875160 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)
NCT03500094 ·Status: COMPLETED ·Phase: PHASE3
-
A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients
NCT00813865 ·Status: COMPLETED ·Phase: PHASE2
-
A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
NCT06858397 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT00074971 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of AT2101 (Afegostat Tartrate) in Adult Patients With Type 1 Gaucher Disease Currently Receiving Enzyme Replacement Therapy
NCT00433147 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
NCT03566017 ·Status: COMPLETED ·Phase: PHASE3
-
French Prospective, Observational Cohort Study of Patients With Fabry Disease Treated With Migalastat
NCT04602364 ·Status: COMPLETED
-
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT00081497 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT00196716 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome
NCT05163808 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Treatment Protocol of Replagal for Patients With Fabry Disease
NCT01031173 ·Status: NO_LONGER_AVAILABLE
-
Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
NCT01124643 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension
NCT02531217 ·Status: COMPLETED ·Phase: PHASE1/PHASE2