Canadian Fabry Disease Initiative (CFDI) National Registry

Study acronym: CFDI-NR
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv12
  2. Minor Site contacts updated at 1 of 5 sitesv11
  3. Re-verified, no change to tracked fieldsv10
  4. Notable Primary and study completion dates: Oct 2019 to Oct 2029v9
  5. Notable Phase: Phase 4 to Not specifiedv8 Show 8 more changesShow less
    • Primary and study completion dates: Mar 2017 to Oct 2019
    • Primary endpoint revised
    • Interventions: Agalsidase beta (Drug), agalsidase alfa (Drug) to No intervention (Other)
    • Eligibility criteria shortened, about 50 words
    • Secondary endpoints: 4 to 2
    • Study description shortened, about 226 words
    • Study arms: 3 to 1
    • Study title shortened, about 3 words
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  1. Minor Study sites revised (5)v7
  2. Re-verified, no change to tracked fieldsv6
  3. Notable Enrollment target: 250 to 600v5 Show 5 more changesShow less
    • Interventions: Enzyme Replacement Therapy (ERT) (Drug), agalsidase alfa (Replagal®) and agalsidase beta (Fabrazyme®) (Drug) to Agalsidase beta (Drug), agalsidase alfa (Drug)
    • Eligibility criteria shortened, about 142 words
    • Study description expanded, about 14 words
    • Site contacts updated at 5 of 5 sites
    • Collaborators: 2 to 1
  4. Re-verified, no change to tracked fieldsv4
  5. Notable Primary endpoints: 6 to 1v3 Show 7 more changesShow less
    • Primary completion date: Mar 2017
    • Interventions: Replagal® (agalsidase alfa) and Fabrazyme® (agalsidase beta) (Drug) to Enzyme Replacement Therapy (ERT) (Drug), agalsidase alfa (Replagal®) and agalsidase beta (Fabrazyme®) (Drug)
    • Eligibility criteria expanded, about 144 words
    • Secondary endpoints expanded, about 78 words
    • Study description expanded, about 13 words
    • Site details revised at 4 of 5 sites
    • Study arms: 0 to 3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2007 to Jan 2007
    • Eligibility criteria revised
    • Site details revised at 5 of 5 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CFDI NATIONAL REGISTRY Fabry disease is a rare, inherited, genetic condition due to a deficiency of an enzyme called alpha-galactosidase A. This enzyme deficiency causes the small blood vessels to accumulate a substance called glycolipid. Without sufficient levels of the enzyme, alpha-galactosidase A, persons with Fabry Disease develop severe neuropathic pain, kidney disease, heart disease, stroke and/or premature death; often before the age of 60. Fabry Disease is estimated to affect approximately one out of every 40,000 males and up to twice as many females in Canada. We do not have the exact number of persons in Canada who have this disease. A common problem in studying rare conditions is the difficulty in identifying the majority of people suffering from such a disease. Gathering their health information in order to better understand the natural disease progression and its response to treatment is difficult. Early ERT studies involving humans had small numbers of subjects and the studies were of short duration. The results of these clinical studies did lead to approval of the therapy in many countries around the world including Canada. To date though, evidence of the usefulness of ERT and its direct impact on the natural course of Fabry disease has been limited, while its cost continues to be very high. As a result of these issues, there will need to be continued and long-term collection of information related to the effectiveness of ERT and other treatments to better document its true clinical outcomes in Canadian people with Fabry disease. The Canadian Fabry Disease Initiative National Registry (CFDI-NR) is an observational, voluntary registry designed to collect outcomes data on Fabry disease from people living in Canada.
Trial Details
NCT Number NCT00455104
Lead Sponsor Canadian Fabry Research Consortium
Collaborators: Nova Scotia Health Authority
Conditions
(from sponsor)
Fabry Disease
Related terms Fabry Disease
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov