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A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)

Study acronym: ITP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from Kedrion S.p.A.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 28 sitesv11
  2. Site details revised at 3 of 28 sitesv10
  3. Primary completion pushed from Aug 2026 to Dec 2026
    • Study completion pushed from Aug 2026 to Jan 2027
    • Study sites: 27 to 28
    v9
  4. Eligibility criteria expanded, about 42 words
    • Site details revised at 1 of 27 sites
    • Collaborators shortened, about 2 words
    v8
  5. Site details revised at 3 of 27 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 4 of 27 sitesv6
  2. Site details revised at 4 of 27 sitesv5
  3. Site details revised at 5 of 27 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Aug 13, 2025
    • Site details revised at 27 of 27 sites
    v3
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Kedrion S.p.A.
6 trials monitored
See 1 trial at risk
The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP
Trial Details
NCT Number NCT07059000
Lead Sponsor Kedrion S.p.A.
Conditions
(from sponsor)		 Chronic Primary Immune Thrombocytopenia (ITP)
Related terms Autoimmune Diseases, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Purpura, Thrombocytopenic, Idiopathic
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov