Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

StatusTerminated
PhasePhase 2
SponsorPfizer
Started

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Record History

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  1. Stopped Trial terminated Sponsor's reason: The study terminated due to a business decision. The decision to terminate the trial was not based on any safety concerns. Show 4 more changesShow less
    • Trial sites reduced: 31 → 24 locations
    • Final enrollment: 61 participants (planned 91)
    • Primary completion date changed from estimate of Aug 2, 2028 to Sep 23, 2026
    • Eligibility criteria shortened, about 19 words
  2. Minor Trial sites expanded: 16 → 31 locationsv48
  3. Minor Trial sites reduced: 31 → 16 locationsv47
  4. Notable Primary and study completion pushed from Oct 1, 2027 to Aug 2, 2028
    • Trial arms changed: 3 → 4
    • Study description shortened, about 1 word
    v46
  5. Minor Study sites: 30 to 31v45
  6. Minor Enrollment increased: 61 → 91 participants
    • Trial sites expanded: 26 → 30 locations
    v44
  7. Minor Study sites: 28 to 26v43
  8. Minor Re-verified, no change to tracked fieldsv42
  9. Minor Study sites: 26 to 28v41
  10. Minor Primary and study completion dates: Oct 28, 2027 to Oct 1, 2027
    • Site details revised at 1 of 26 sites
    v40
  11. Notable Primary and study completion dates: Oct 27, 2026 to Oct 28, 2027
    • Study sites: 30 to 26
    v39
  12. Minor Secondary endpoints: details revised at 1 of 6 entries
    • Study sites revised (30)
    • Study arms: 2 to 3
    • Study description expanded, about 4 words
    v38
  13. Minor Primary and study completion dates: May 17, 2027 to Oct 27, 2026
    • Study sites revised (30)
    v37
  14. Notable Primary and study completion dates: Mar 21, 2025 to May 17, 2027v36
  15. Minor Study sites: 29 to 30v35
  16. Minor Re-verified, no change to tracked fieldsv34
  17. Minor Site details revised at 2 of 29 sitesv33
  18. Minor Site details revised at 2 of 29 sitesv32
  19. Minor Site details revised at 7 of 29 sitesv31
  20. Minor Site details revised at 2 of 29 sitesv30
  21. Notable Trial status: Suspended to Recruiting
    • Study sites: 28 to 29
    v29
  22. Minor Study sites revised (28)v28
  23. Notable Primary and study completion dates: Oct 22, 2023 to Mar 21, 2025v27
  24. Stopped Trial status: Recruiting to Suspended Sponsor's reason: pause for interim analysis.v26 Show 6 more changesShow less
    • Enrollment target: 40 to 61
    • Primary endpoint revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 13 words
    • Site details revised at 28 of 28 sites
    • Study arms: 1 to 2
  25. Minor Study sites: 27 to 28v25
  26. Minor Study sites: 26 to 27v24
  27. Minor Study sites: 25 to 26v23
  28. Minor Study sites revised (25)v22
  29. Minor Study sites: 24 to 25v21
  30. Minor Study sites: 23 to 24v20
  31. Minor Site details revised at 1 of 23 sitesv19
  32. Minor Re-verified, no change to tracked fieldsv18
  33. Minor Study sites: 22 to 23v17
  34. Minor Study sites: 20 to 22v16
  35. Minor Study sites: 18 to 20v15
  36. Minor Site details revised at 2 of 18 sitesv14
  37. Minor Study sites: 17 to 18v13
  38. Minor Study sites: 16 to 17v12
  39. Minor Study sites: 14 to 16v11
  40. Minor Study sites: 13 to 14v10
  41. Minor Study sites: 12 to 13v9
  42. Minor Study sites: 7 to 12v8
  43. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2022 to Feb 2, 2022
    • Site details revised at 7 of 7 sites
    v7
  44. Minor Study sites: 6 to 7v6
  45. Minor Study sites: 4 to 6v5
  46. Notable Start date: Nov 15, 2021 to Jan 31, 2022v4
  47. Minor Study sites: 1 to 4v3
  48. Minor Study sites: 0 to 1
    • Start date: Nov 14, 2021 to Nov 15, 2021
    v2
  49. Minor 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.
438 trials monitored
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This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP
Trial Details
NCT Number NCT05070845
Lead Sponsor Pfizer
Conditions
(from sponsor)
Primary Immune Thrombocytopenia
Related terms Purpura, Thrombocytopenic, Idiopathic
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov