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A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site details revised at 2 of 114 sitesv15
  2. Study sites: 112 to 114v14
  3. Trial sites expanded: 109 → 112 locationsv13
  4. Study sites: 105 to 109v12
  5. Study sites: 103 to 105v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 101 to 103v10
  2. Primary completion date: Jul 2026 to Sep 2027v9 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 150 to 176
    • Study sites: 99 to 101
    • Study completion date: Aug 2026 to Nov 2027
    • Eligibility criteria shortened, about 1 word
  3. Study sites: 80 to 99v8
  4. Primary endpoints revised (2)v7 Show 4 more changesShow less
    • Study sites: 51 to 80
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints revised (5)
    • Study description revised
  5. Study sites: 12 to 51
    • Eligibility criteria expanded, about 78 words
    v6
  6. Primary endpoints revised (2)v5 Show 4 more changesShow less
    • Study sites: 4 to 12
    • Start date changed from estimate of Jul 2024 to Jun 6, 2024
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints revised (5)
  7. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date: Jun 2025 to Jul 2026
    • Start date: Mar 2024 to Jul 2024
    • Primary endpoints revised (2)
    • Study sites: 0 to 4
    • Study completion date: Jul 2025 to Aug 2026
  8. Start date: Feb 2024 to Mar 2024v3
  9. Primary endpoints revised (2)v2 Show 7 more changesShow less
    • Enrollment target: 128 to 150
    • Primary completion date: Jan 2025 to Jun 2025
    • Study completion date: Apr 2025 to Jul 2025
    • Start date: Jan 2024 to Feb 2024
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: 14 to 5
    • Study description expanded, about 2 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.
Trial Details
NCT Number NCT06056297
Lead Sponsor X4 Pharmaceuticals
Conditions
(from sponsor)		 Neutropenia
Related terms Autoimmune Diseases, Barth Syndrome, Cohen syndrome, Neutropenia, Neutropenia, Severe Congenital, Autosomal Recessive 3, Shwachman-Diamond Syndrome
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov