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Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Study acronym: VAY RE-HIT
StatusWithdrawn
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: The study was discontinued due to evolving scientific \& feasibility considerations that could adversely affect recruitment, thereby reducing the likelihood of generating a sufficiently robust dataset to support reliable efficacy \& safety conclusions. Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 0
    • Trial sites reduced: 25 → 0 locations
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 6 of 10 entries
  2. Trial sites expanded: 22 → 25 locationsv13
  3. Trial sites expanded: 18 → 22 locationsv12
  4. Start date: Apr 27, 2026 to Jun 26, 2026
    • Trial sites expanded: 14 → 18 locations
    v11
  5. Trial sites expanded: 10 → 14 locationsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 9 to 10v9
  2. Study sites: 4 to 9v8
  3. Start date: Jan 30, 2026 to Apr 27, 2026
    • Study sites: 1 to 4
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  5. Start date: Oct 3, 2025 to Jan 30, 2026v5
  6. Start date: Aug 1, 2025 to Oct 3, 2025v4
  7. Secondary endpoints: 9 to 10v3
  8. Study title shortened, about 1 wordv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
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This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).
Trial Details
NCT Number NCT07039422
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Related terms Purpura, Thrombocytopenic, Idiopathic
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov