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Retrospective and Prospective Observational Study of MRI Changes in Bone and Visceral Lesions of Patients With Type 1 Gaucher Disease Treated With VPRIV® (Velaglucerase Alfa)

NCT03333447 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-06-22

No results posted yet for this study

Summary

This study with standardized reading MRIs, will provide for the first time objective and quantified data on organomegaly (liver and spleen volumes) as well as bone alteration (Bone Marrow Burden11) of French patients treated with VPRIV®. These data will help to better assess the impact of this treatment on these parameters.

The result of this study will also answer in part to the request of the French Transparency Commission (CT: Commission de Transparence) of the French National Health Authority to provide them with data of French patients treated with VPRIV®.

Conditions

  • Gaucher Disease, Type 1
  • MRI

Interventions

OTHER

MRI

Sponsors & Collaborators

  • BioClinica, Inc.

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • CEN Biotech

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2017-09-13
Completion
2018-12-27

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333447 on ClinicalTrials.gov