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NCT00446550 · ClinicalTrials.gov registry record · Phase 2

A Study of Oral AT2101 (Afegostat Tartrate) in Treatment-naive Patients With Gaucher Disease

A Phase 2 study of Gaucher Disease and Gaucher Disease, Type 1, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target
11
Study locations

NCT00446550 is a Phase 2 study of Gaucher Disease and Gaucher Disease, Type 1 that has completed, run by Amicus Therapeutics. The registered enrollment target is 19 participants, below the 1,057-participant average among 13 other Gaucher Disease trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT00446550, a Phase 2 study of Gaucher Disease and Gaucher Disease, Type 1, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target
11
Study locations

Study Summary

This study evaluated the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease who were not receiving enzyme replacement therapy (ERT) or substrate reduction therapy (SRT).

Conditions Studied

Gaucher Disease Gaucher Disease, Type 1 Type 1 Gaucher Disease

Interventions

  • DRUG afegostat tartrate

Study Locations (11)

Other

  • - Haifa
  • - Tel Aviv
  • - Johannesburg
  • - London

California

  • - Beverly Hills

Florida

  • - Coral Springs

Georgia

  • - Decatur

Iowa

  • - Iowa City

Kansas

  • - Kansas City

Massachusetts

  • - Boston

Ohio

  • - Cincinnati

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2008-06-11
Est. Completion 2009-08-20
Phase Phase 2

Sponsor

Amicus Therapeutics

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00446550

The ClinicalTrials.gov registry entry for NCT00446550 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,057-participant average among 13 other Gaucher Disease trials with a reported enrollment target (98% lower). The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Gaucher Disease appearing as the primary indexed condition, and to 1 intervention - of which afegostat tartrate is the first listed.

NCT00446550 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00446550 about?

NCT00446550 is a clinical study titled "A Study of Oral AT2101 (Afegostat Tartrate) in Treatment-naive Patients With Gaucher Disease". This study evaluated the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease who were not receiving enzyme replacement therapy (ERT) or substrate reduction therapy (SRT).

What is the current status of trial NCT00446550?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2008-06-11. Estimated completion is 2009-08-20.

What conditions does trial NCT00446550 study?

This clinical trial studies the following conditions: Gaucher Disease, Gaucher Disease, Type 1, Type 1 Gaucher Disease.

What interventions are being tested in trial NCT00446550?

The interventions under investigation include: afegostat tartrate (DRUG).

Who is sponsoring clinical trial NCT00446550?

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

Where is trial NCT00446550 being conducted?

This trial has 11 study locations across California, Florida, Georgia, Iowa, Kansas. 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.