Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06008938 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

Study acronym: IX-TEND 4001
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 10 to 12v7
  2. Study sites: 9 to 10v6
  3. Study sites: 1 to 9 Primary and study completion dates: Aug 2043 to Aug 1, 2043 · Eligibility criteria expanded, about 4 wordsv5 Show 2 more changesShow less
    • Primary and study completion dates: Aug 2043 to Aug 1, 2043
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv4
  5. Site contact updatedv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2023 to Jun 15, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2023 to Jun 15, 2023
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.
Trial Details
NCT Number NCT06008938
Lead Sponsor CSL Behring
Conditions Hemophilia B
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov