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NCT01218659 · ClinicalTrials.gov registry record · Phase 3

Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease

A Phase 3 study of Fabry Disease, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 3
Development phase
68
Enrollment target
20
Study locations

NCT01218659 is a Phase 3 study of Fabry Disease that has completed, run by Amicus Therapeutics. The registered enrollment target is 68 participants, below the 541-participant average among 32 other Fabry Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01218659, a Phase 3 study of Fabry Disease, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
68 participants
Enrollment target
20
Study locations

Study Summary

Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the clinical trial human embryonic kidney cell (HEK) assay.

Conditions Studied

Fabry Disease

Interventions

  • DRUG migalastat hydrochloride
  • BIOLOGICAL agalsidase

Study Locations (20)

Other

  • - Vienna
  • - Edegem
  • - São Paulo
  • - Copenhagen
  • - Garches
  • - Lille
  • - Florence
  • - Niigata
  • - Osaka
  • - Osaka

California

  • - Los Angeles

Colorado

  • - Aurora

Georgia

  • - Decatur

Michigan

  • - Grand Rapids

Oregon

  • - Portland

Pennsylvania

  • - Pittsburgh

Virginia

  • - Fairfax

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2011-09-08
Est. Completion 2015-05-28
Phase Phase 3

Sponsor

Amicus Therapeutics

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01218659

The ClinicalTrials.gov registry entry for NCT01218659 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 541-participant average among 32 other Fabry Disease trials with a reported enrollment target (87% lower). The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 2 interventions - of which migalastat hydrochloride is the first listed.

NCT01218659 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01218659 about?

NCT01218659 is a clinical study titled "Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease". Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the clinical trial human em...

What is the current status of trial NCT01218659?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2011-09-08. Estimated completion is 2015-05-28.

What conditions does trial NCT01218659 study?

This clinical trial studies the following conditions: Fabry Disease.

What interventions are being tested in trial NCT01218659?

The interventions under investigation include: migalastat hydrochloride (DRUG), agalsidase (BIOLOGICAL).

Who is sponsoring clinical trial NCT01218659?

This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01218659 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Michigan, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.