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ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 71 → 76 locationsv51
  2. Site contacts updated at 1 of 71 sitesv50
  3. Study sites: 72 to 71v49
  4. Primary endpoints: 2 to 1v48 Show 5 more changesShow less
    • Study sites: 73 to 72
    • Eligibility criteria expanded, about 352 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 150 words
    • Collaborators revised (7)
  5. Study sites: 74 to 73v47
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 75 to 74v46
  2. Study sites: 74 to 75v45
  3. Study description shortened, about 13 wordsv44
  4. Study sites: 73 to 74v43
  5. Study sites: 72 to 73v42
  6. Study sites: 71 to 72v41
  7. Study sites revised (71)v40
  8. Study sites: 69 to 71v39
  9. Study sites revised (69)v38
  10. Study sites: 68 to 69v37
  11. Collaborators: 6 to 7v36
  12. Study sites: 67 to 68v35
  13. Eligibility criteria expanded, about 1,121 wordsv34
  14. Study sites: 66 to 67
    • Study description shortened, about 27 words
    v33
  15. Site contacts updated at 1 of 66 sitesv32
  16. Site contacts updated at 1 of 66 sitesv31
  17. Re-verified, no change to tracked fieldsv30
  18. Primary endpoints: 1 to 2
    • Study sites: 65 to 66
    v29
  19. Site details revised at 10 of 65 sitesv28
  20. Site details revised at 1 of 65 sitesv27
  21. Study sites: 63 to 65
    • Study description expanded, about 427 words
    v26
  22. Study sites: 62 to 63v25
  23. Study sites: 60 to 62v24
  24. Study sites: 59 to 60v23
  25. Study sites: 45 to 59v22
  26. Study sites: 43 to 45v21
  27. Collaborators: 5 to 6v20
  28. Re-verified, no change to tracked fieldsv19
  29. Study sites: 39 to 43v18
  30. Study sites: 38 to 39v17
  31. Study sites: 37 to 38v16
  32. Study sites: 36 to 37v15
  33. Study sites: 32 to 36v14
  34. Study sites: 31 to 32v13
  35. Study description revisedv12
  36. Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Study description shortened, about 20 words
    • Collaborators: 3 to 5
    v11
  37. Study sites: 30 to 31v10
  38. Primary endpoint revisedv9 Show 4 more changesShow less
    • Study sites: 28 to 30
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (5)
    • Study description revised
  39. Study sites: 10 to 28v8
  40. Re-verified, no change to tracked fieldsv7
  41. Collaborators expanded, about 7 wordsv6
  42. Study sites: 1 to 10v5
  43. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v4
  44. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Sep 2020 to Sep 30, 2020
    v3
  45. Start date: Jun 2020 to Sep 2020v2
  • 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.
In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.2,3,4,5 In 2019 alone, the FDA has issued approvals for 24 new therapies for congenital and acquired hematologic conditions.6 In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.7 With this increase in potential new therapies possible, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.8
Trial Details
NCT Number NCT04398628
Lead Sponsor American Thrombosis and Hemostasis Network
Collaborators: Pfizer, Hemophilia of Georgia, Inc., Genentech, Inc., CSL Behring, Sanofi, Novo Nordisk A/S, Hemab ApS
Conditions
(from sponsor)		 Hematologic Disorder, Bleeding Disorder, Connective Tissue Disorder, Hemophilia, Thrombosis, Von Willebrand Diseases, Thrombophilia, Rare Bleeding Disorder +5 more
Related terms Anemia, Sickle Cell, Blood Platelet Disorders, Connective Tissue Diseases, Hematologic Diseases, Hemophilia A, Hemophilia B, Hemostatic Disorders, Thalassemia, Thrombophilia, Thrombosis, von Willebrand Diseases
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov