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Observatory of Patients With Haemophilia B Treated by IdElvion®

Study acronym: OrPHEe
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 222 · Site details revised at 28 of 28 sitesv19 Show 2 more changesShow less
    • Enrollment target: estimated 100 to confirmed 222
    • Site details revised at 28 of 28 sites
  2. Re-verified, no change to tracked fieldsv18
  3. Primary and study completion dates: Sep 2026 to Dec 2027v17
  4. Site details revised at 3 of 28 sitesv16
  5. Study sites: 25 to 28v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 1 of 25 sitesv14
  2. Study sites: 24 to 25v13
  3. Site details revised at 1 of 24 sitesv12
  4. Re-verified, no change to tracked fieldsv11
  5. Site details revised at 1 of 24 sitesv10
  6. Study sites: 23 to 24v9
  7. Study sites: 22 to 23 Eligibility criteria expanded, about 3 wordsv8 Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Site details revised at 3 of 22 sitesv7
  9. Study sites: 20 to 22v6
  10. Start date changed from estimate of Dec 2021 to Dec 3, 2021 Site details revised at 3 of 20 sitesv5 Show 1 more changeShow less
    • Site details revised at 3 of 20 sites
  11. Re-verified, no change to tracked fieldsv4
  12. Study sites: 16 to 20 Start date: Nov 2021 to Dec 2021v3 Show 1 more changeShow less
    • Start date: Nov 2021 to Dec 2021
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 7 to 16 · Start date: Oct 2021 to Nov 2021 · Study description expanded, about 162 wordsv2 Show 3 more changesShow less
    • Study sites: 7 to 16
    • Start date: Oct 2021 to Nov 2021
    • Study description expanded, about 162 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Hemophilia
236 trials monitored
See 12 trials at risk
OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.
Trial Details
NCT Number NCT05086575
Lead Sponsor CSL Behring
Conditions Haemophilia B
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov