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NCT06039020

ATGAM General Investigation

StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

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Record History

All 18 versions: 8 with changes below, 10 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 2 words
    • Primary and study completion pushed from Jan 22, 2027 to Mar 26, 2027
  2. Enrollment target: 6 to 1v8
  3. Enrollment target: 5 to 6v7
  4. Enrollment target: estimated 100 to confirmed 5
    • Primary and study completion dates: Feb 13, 2026 to Jan 22, 2027
    v6
  5. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 29, 2024 to Feb 21, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 30, 2023 to Feb 29, 2024
    • Primary and study completion dates: Feb 16, 2026 to Feb 13, 2026
    v3
  2. Start date: Sep 28, 2023 to Nov 30, 2023
    • Primary and study completion dates: Mar 12, 2026 to Feb 16, 2026
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with adverse drug reactions (ADRs)
Timeframe: 24 weeks (6 months) from the start of administration (Day 1)

Arms and interventions

Anti-human thymocyte immunoglobulin, equine

Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)

Drugs: Anti-human thymocyte immunoglobulin, equine

Sites

1 site in 1 country

  • PfizerTokyo, Japan