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Two Dose Levels of Privigen in Pediatric CIDP

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 9 sitesv37
  2. Site details revised at 1 of 9 sites Eligibility criteria expanded, about 2 wordsv36 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv35
  4. Site details revised at 1 of 9 sitesv34
  5. Site details revised at 1 of 9 sitesv33
Show 31 earlier versionsHide 31 earlier versions
  1. Site details revised at 1 of 9 sitesv32
  2. 2 versions Re-verified since Dec 5, 2024, no change to tracked fieldsv30-v31
  3. Study sites: 8 to 9v29
  4. Site details revised at 1 of 8 sitesv28
  5. Site details revised at 1 of 8 sitesv27
  6. 2 versions Re-verified since Feb 28, 2024, no change to tracked fieldsv25-v26
  7. Study sites: 7 to 8v24
  8. Study sites: 6 to 7v23
  9. Study sites: 5 to 6v22
  10. Re-verified, no change to tracked fieldsv21
  11. Primary and study completion dates: Jan 2027 to Dec 20, 2029 Study sites: 9 to 5v20 Show 1 more changeShow less
    • Study sites: 9 to 5
  12. Primary completion date: Aug 2022 to Jan 2027 Primary endpoint revised · Completion date: Jan 2023 to Jan 2027 · Eligibility criteria shortened, about 19 words · 2 morev19 Show 5 more changesShow less
    • Primary endpoint revised
    • Completion date: Jan 2023 to Jan 2027
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints: 9 to 15
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 10 to 9v18
  14. Study sites: 13 to 10v17
  15. Re-verified, no change to tracked fieldsv16
  16. Site details revised at 2 of 13 sitesv15
  17. Site details revised at 3 of 13 sitesv14
  18. Trial status: Active, Not Recruiting to Recruiting Site details revised at 13 of 13 sitesv13 Show 1 more changeShow less
    • Site details revised at 13 of 13 sites
  19. Trial status: Recruiting to Active, Not Recruiting Site details revised at 13 of 13 sitesv12 Show 1 more changeShow less
    • Site details revised at 13 of 13 sites
  20. Eligibility criteria expanded, about 19 wordsv11 See this version in full on ClinicalTrials.gov ↗
  21. Site details revised at 1 of 13 sitesv10
  22. Re-verified, no change to tracked fieldsv9
  23. Study sites revised (13)v8 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 6 to 13v7
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Start date changed from estimate of Mar 2019 to Feb 28, 2019v6 Show 2 more changesShow less
    • Study sites: 0 to 6
    • Start date changed from estimate of Mar 2019 to Feb 28, 2019
  26. Start date: Feb 2019 to Mar 2019v5
  27. Start date: Jan 2019 to Feb 2019v4
  28. Start date: Nov 2018 to Jan 2019v3
  29. Start date: Oct 2018 to Nov 2018v2
  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.
CSL Behring
30 trials monitored
See 2 trials at risk
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
Trial Details
NCT Number NCT03684018
Lead Sponsor CSL Behring
Conditions Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov