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NCT00376168 · ClinicalTrials.gov registry record · Phase 3

A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease

A Phase 3 study of Gaucher Disease, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
32
Enrollment target
11
Study locations

NCT00376168 is a Phase 3 study of Gaucher Disease that has completed, run by Pfizer. The registered enrollment target is 32 participants, below the 1,056-participant average among 13 other Gaucher Disease trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 5 states.

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The verdict

NCT00376168, a Phase 3 study of Gaucher Disease, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
32 participants
Enrollment target
11
Study locations

Study Summary

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.

Conditions Studied

Gaucher Disease

Interventions

  • DRUG Plant cell expressed recombinant glucocerebrosidase (prGCD)

Study Locations (11)

Other

  • Pontificia Universidad Catolica de Chile - Santiago
  • Rambam Medical Center - Haifa
  • Shaare Zedek Medical Center - Jerusalem
  • Universita "La Sapienza" - Rome
  • Morningside Medi-Clinic - Morningside
  • Hospital Universitario Miguel Servet - Zaragoza
  • Royal Free Hospital - London

Florida

  • University Research Foundation for Lysosomal Storage Diseases - Coral Springs

Georgia

  • Division of Medical Genetics, Emory University School of Medicine - Decatur

New York

  • New York University Medical Center - New York

Ontario

  • Mount Sinai Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2007-08
Est. Completion 2009-10
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00376168

The ClinicalTrials.gov registry entry for NCT00376168 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,056-participant average among 13 other Gaucher Disease trials with a reported enrollment target (97% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gaucher Disease appearing as the primary indexed condition, and to 1 intervention - of which Plant cell expressed recombinant glucocerebrosidase (prGCD) is the first listed.

NCT00376168 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00376168 about?

NCT00376168 is a clinical study titled "A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease". Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte...

What is the current status of trial NCT00376168?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2007-08. Estimated completion is 2009-10.

What conditions does trial NCT00376168 study?

This clinical trial studies the following conditions: Gaucher Disease.

What interventions are being tested in trial NCT00376168?

The interventions under investigation include: Plant cell expressed recombinant glucocerebrosidase (prGCD) (DRUG).

Who is sponsoring clinical trial NCT00376168?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00376168 being conducted?

This trial has 11 study locations across Florida, Georgia, New York, Ontario. 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.