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Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Study acronym: pHeNIx
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 1 of 27 sitesv24
  2. Minor Re-verified, no change to tracked fieldsv23
  3. Minor Study sites: 26 to 27v22
  4. Notable Primary and study completion dates: Sep 2024 to Dec 2027 Study sites: 24 to 26v21 Show 1 more changeShow less
    • Study sites: 24 to 26
  5. Minor Site details revised at 3 of 24 sitesv20
Show 18 earlier versionsHide 18 earlier versions
  1. Minor Site details revised at 1 of 24 sitesv19
  2. Minor Site details revised at 2 of 24 sitesv18
  3. Minor Study sites: 22 to 24v17
  4. Minor Study sites: 21 to 22v16
  5. Minor Study sites: 20 to 21v15
  6. Minor Site details revised at 1 of 20 sitesv14
  7. Minor Site details revised at 3 of 20 sitesv13
  8. Minor Study sites: 17 to 20v12
  9. Minor Study sites: 18 to 17v11
  10. Minor Study sites: 17 to 18 Start date changed from estimate of Jun 2022 to Jun 10, 2022v10 Show 1 more changeShow less
    • Start date changed from estimate of Jun 2022 to Jun 10, 2022
  11. Minor Start date: May 2022 to Jun 2022 Site details revised at 6 of 17 sitesv9 Show 1 more changeShow less
    • Site details revised at 6 of 17 sites
  12. Notable Trial status: Suspended to Recruiting Start date: Mar 2022 to May 2022 · Site details revised at 17 of 17 sitesv8 Show 2 more changesShow less
    • Start date: Mar 2022 to May 2022
    • Site details revised at 17 of 17 sites
  13. Minor Study sites revised (17)v7 See this version in full on ClinicalTrials.gov ↗
  14. Minor Eligibility criteria shortened, about 1 wordv6 See this version in full on ClinicalTrials.gov ↗
  15. Stopped Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Suspended due to the COVID situationv5
  16. Notable Primary and study completion dates: Sep 2023 to Sep 2024 Start date: Mar 2021 to Mar 2022v4 Show 1 more changeShow less
    • Start date: Mar 2021 to Mar 2022
  17. Minor Re-verified, no change to tracked fieldsv3
  18. Notable Start date: Dec 2020 to Mar 2021 Secondary endpoints revised (18)v2 Show 1 more changeShow less
    • Secondary endpoints revised (18)

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
30 trials monitored
See 2 trials at risk
The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).
Trial Details
NCT Number NCT04672733
Lead Sponsor CSL Behring
Conditions Chronic Inflammatory Demyelinating Polyneuropathy
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov