Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia

Study acronym: RATGAA07
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary endpoint revised
    • Secondary endpoint revised
    v7
  3. Results first posted: Oct 18, 2021v6 Show 8 more changesShow less
    • Primary completion date: Sep 2010 to Oct 2011
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2012 to Feb 2013
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoint revised
    • Study description expanded, about 10 words
    • Publications: details revised at 1 of 1 entry
  4. Primary completion date changed from estimate of Jan 2010 to Sep 2010
    • Study completion date: Dec 2010 to Dec 2012
    v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 14 of 14 sites
    v4
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  1. Study sites: 5 to 14v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jul 2007 to Aug 2008
    • Primary completion date: Jan 2010
    • Interventions: Rabbit antithymocyte globulin (ATG, Thymoglobulin) (Drug) to rabbit antithymocyte globulin (Drug)
    • Site details revised at 5 of 5 sites
    • Study arms: 0 to 1
  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.
To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG, Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion dependent.
Trial Details
NCT Number NCT00471848
Lead Sponsor European Society for Blood and Marrow Transplantation
Collaborators: Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Aplastic Anemia
Related terms Anemia, Aplastic
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov