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NCT03291223

Gaucher Disease Outcome Survey (GOS)

StatusRecruiting
PhaseNot specified
SponsorShire
Primary completion (estimated)

At risk: Primary completion moved 2 years later.

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Record History

All 14 versions: 11 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2028
    • Eligibility criteria expanded, about 2 words
    • Publications: details revised at 3 of 3 entries
  2. Start date: Jul 27, 2010 to Dec 29, 2010v13
  3. Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026v12
  4. Primary and study completion dates: Jan 3, 2025 to Sep 30, 2025v11
  5. Primary and study completion dates: May 31, 2024 to Jan 3, 2025v10
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Dec 15, 2023 to May 31, 2024v9
  2. Primary and study completion dates: Dec 15, 2021 to Dec 15, 2023v7
  3. Primary and study completion dates: Dec 1, 2020 to Dec 15, 2021v6
  4. Trial status: Active, Not Recruiting to Recruiting
    • Study description expanded, about 51 words
    • Site details revised
    v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study description expanded, about 34 words
    • Site details revised
    v4
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline to one year for up to 20 years
Number of Participants With Infusion-related Reactions (IRRs)
Timeframe: Baseline to one year for up to 20 years
Increase of Hemoglobin Concentration
Timeframe: Baseline to one year for up to 20 years
Increase of Platelet Count
Timeframe: Baseline to one year for up to 20 years
Decrease in Liver Volume
Timeframe: Baseline to one year for up to 20 years
Decrease in Spleen Volume
Timeframe: Baseline to one year for up to 20 years
Increase in Bone Mineral Density (BMD)
Timeframe: Baseline to one year for up to 20 years

Arms and interventions

GOS Participants

GOS is a disease specific registry open to all Gaucher patients irrespective of treatment status or type of treatment

Sites

1 site in 1 country

  • Central ContactLexington, Massachusetts, United States