Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients

StatusTerminated
PhasePhase 4
Started

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Record History

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  1. Trial terminated Sponsor's reason: Due to recruitment challenges during the trial, this study was terminated early by the Sponsor. Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Results posted: Sep 30, 2026
    • Start date: Sep 2007 to Jul 8, 2008
    • Final enrollment: 4 participants (planned 15)
    • Primary completion date changed from estimate of Dec 2028 to Feb 6, 2012
    • Interventions: Alphanate SD/HT (Biological) to Alphanate SD/HT (Biological)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 2 to 1
  2. Re-verified, no change to tracked fieldsv16
  3. Secondary endpoints: details revised at 1 of 2 entriesv15
  4. 2 versions Re-verified since Apr 9, 2019, no change to tracked fieldsv13-v14
  5. Primary completion date: Dec 2020 to Dec 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 0
    • Study completion date: Mar 2021 to Mar 2029
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Dec 2016 to Dec 2020
    • Study completion date: Mar 2017 to Mar 2021
    v11
  2. Re-verified, no change to tracked fieldsv10
  3. Study sites: 4 to 2v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary endpoints: 2 to 1
    • Secondary endpoints: 1 to 2
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Primary completion date: Dec 2010 to Dec 2016
    • Study completion date: Dec 2010 to Mar 2017
    • Site contacts updated at 4 of 4 sites
    v5
  8. Re-verified, no change to tracked fieldsv4
  9. Interventions: Plasma-derived FVIII/VWF concentrate (Drug) to Alphanate SD/HT (Biological)
    • Study arms: 0 to 1
    v3
  10. Primary endpoints: 3 to 2
    • Study sites: 1 to 4
    • Primary completion date: Dec 2010
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.
Trial Details
NCT Number NCT00555555
Lead Sponsor Grifols Biologicals, LLC
Conditions
(from sponsor)		 Von Willebrand Disease
Related terms Hematologic Diseases, Hemophilia A, Hemostatic Disorders, von Willebrand Diseases
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov