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NCT02574286 · ClinicalTrials.gov registry record · Phase 4

Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease

A Phase 4 study of Gaucher Disease, sponsored by Shire.

Completed
Registry status
Phase 4
Development phase
21
Enrollment target
15
Study locations

NCT02574286 is a Phase 4 study of Gaucher Disease that has completed, run by Shire. The registered enrollment target is 21 participants, below the 1,057-participant average among 13 other Gaucher Disease trials with a reported enrollment target (98% lower). The trial reports 15 study locations across 8 states.

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The verdict

NCT02574286, a Phase 4 study of Gaucher Disease, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 4
Development phase
21 participants
Enrollment target
15
Study locations

Study Summary

The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram \[U/kg\] every other week \[EOW\]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar spine (LS) bone mineral density (BMD) Z-score as measured by dual energy x-ray absorptiometry (DXA) after 24 months of treatment.

Conditions Studied

Gaucher Disease

Interventions

  • DIETARY_SUPPLEMENT Vitamin D
  • DRUG Velaglucerase alfa

Study Locations (15)

Other

  • Rambam Health Care Campus - Haifa
  • Shaare Zedek Medical Center - Jerusalem
  • Rabin Medical Center - Petah Tikva
  • Hospital Universitario Ramon y Cajal - Madrid
  • Hospital Quironsalud Zaragoza - Zaragoza
  • Addenbrooke's Hospital - Cambridge
  • Royal Free Hospital - London

California

  • Cedars Sinai Medical Center - Beverly Hills
  • Kaiser Permanente - Los Angeles

Georgia

  • Emory Genetics - Atlanta

Illinois

  • Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago

New York

  • NYU School of Medicine - New York

North Carolina

  • Duke University Medical Center - Durham

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Virginia

  • Lysosomal and Rare Disorders Research and Treatment Center - Fairfax

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2016-06-29
Est. Completion 2020-11-30
Phase Phase 4

Sponsor

Shire

245 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02574286

The ClinicalTrials.gov registry entry for NCT02574286 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 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 Shire, which has 245 total studies on file at ClinicalTrials.gov.

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

NCT02574286 reports 15 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT02574286 about?

NCT02574286 is a clinical study titled "Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease". The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram \[U/kg\] every other week \[EOW\]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar spine (LS) bone mineral density (BMD) Z-score as measured by dual energ...

What is the current status of trial NCT02574286?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2016-06-29. Estimated completion is 2020-11-30.

What conditions does trial NCT02574286 study?

This clinical trial studies the following conditions: Gaucher Disease.

What interventions are being tested in trial NCT02574286?

The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Velaglucerase alfa (DRUG).

Who is sponsoring clinical trial NCT02574286?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02574286 being conducted?

This trial has 15 study locations across California, Georgia, Illinois, New York, North Carolina. 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.