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Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 40 days later Mar 6, 2028 → Apr 15, 2028
See other at-risk trials from CSL Behring

Record History

  1. Primary completion pushed from Mar 6, 2028 to Apr 15, 2028 Completion pushed from Apr 6, 2028 to May 15, 2028 · Study sites: 99 to 100 · Eligibility criteria expanded, about 8 words · 1 more Show 4 more changesShow less
    • Completion pushed from Apr 6, 2028 to May 15, 2028
    • Study sites: 99 to 100
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 11 of 27 entries
  2. Secondary endpoints revised (27)v10 See this version in full on ClinicalTrials.gov ↗
  3. Secondary endpoints revised (27) Study sites revised (99) · Eligibility criteria shortened, about 3 wordsv9 Show 2 more changesShow less
    • Study sites revised (99)
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 2 of 99 sitesv8
  5. Study sites: 98 to 99v7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria revised Secondary endpoints revised (27)v6 Show 1 more changeShow less
    • Secondary endpoints revised (27)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 96 to 98v5
  3. Start date changed from estimate of Feb 8, 2026 to Jan 22, 2026 Study sites revised (96)v4 Show 1 more changeShow less
    • Study sites revised (96)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 2 to 96v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary completion date: Feb 18, 2028 to Mar 6, 2028 · Completion date: Mar 18, 2028 to Apr 6, 2028 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Feb 18, 2028 to Mar 6, 2028
    • Completion date: Mar 18, 2028 to Apr 6, 2028
    • Start date: Jan 20, 2026 to Feb 8, 2026
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study to assess vamifeport in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH). The primary objective of the study is to assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with HFE-HH.
Trial Details
NCT Number NCT07332091
Lead Sponsor CSL Behring
Conditions Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov