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Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate

StatusTerminated
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: Due to recruitment challenges during the trial, this study was terminated early by the Sponsor. Primary endpoint(s) modified · Sponsor changed: Grifols Biologicals, LLC to Instituto Grifols, S.A. · Results posted: Oct 7, 2026 · 7 more Show all 11 changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Grifols Biologicals, LLC to Instituto Grifols, S.A.
    • Results posted: Oct 7, 2026
    • Start date: Jan 2006 to Apr 15, 2008
    • Final enrollment: 3 participants (planned 30)
    • Primary completion date changed from estimate of Dec 2028 to Dec 2011
    • Study completion date changed from estimate of Mar 2029 to Dec 16, 2011
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints shortened, about 29 words
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv17
  3. Study title revised Eligibility criteria shortened, about 1 word · Study description expanded, about 1 wordv16 Show all 3 changesShow less
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Apr 9, 2019, no change to tracked fieldsv14-v15
  5. Primary completion date: Dec 2018 to Dec 2028 Trial status: Recruiting to Active, Not Recruiting · Study sites: 2 to 0 · Completion date: Mar 2019 to Mar 2029v13 Show all 4 changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 0
    • Completion date: Mar 2019 to Mar 2029
Show 11 earlier versionsHide 11 earlier versions
  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Dec 2017 to Dec 2018 Completion date: Mar 2018 to Mar 2019v11 Show all 2 changesShow less
    • Completion date: Mar 2018 to Mar 2019
  3. Study sites: 3 to 2v10
  4. 3 versions Re-verified since Sep 6, 2011, no change to tracked fieldsv7-v9
  5. Primary completion date: Dec 2012 to Dec 2017 Study sites: 5 to 3 · Completion date: Jan 2013 to Mar 2018v6 Show all 3 changesShow less
    • Study sites: 5 to 3
    • Completion date: Jan 2013 to Mar 2018
  6. Re-verified, no change to tracked fieldsv5
  7. Primary completion date: Dec 2010 to Dec 2012 Completion date: Dec 2010 to Jan 2013 · Study arms: 0 to 1v4 Show all 3 changesShow less
    • Completion date: Dec 2010 to Jan 2013
    • Study arms: 0 to 1
  8. Study sites: 1 to 5v3
  9. Primary completion date: Dec 2010 Completion date: Dec 2007 to Dec 2010 · Secondary endpoints: details revised at 1 of 1 entryv2 Show all 3 changesShow less
    • Completion date: Dec 2007 to Dec 2010
    • Secondary endpoints: details revised at 1 of 1 entry
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
Trial Details
NCT Number NCT00319228
Lead Sponsor Instituto Grifols, S.A.
Conditions Antithrombin III Deficiency
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov