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COMPLETED Phase 4

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

NCT02574286 · View on ClinicalTrials.gov ↗

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

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

56 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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02574286 reports 15 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02574286?

The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Velaglucerase alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02574286?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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