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Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study completion date: Jun 30, 2026 to Jun 30, 2027v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 36
    • Primary completion date: Jun 30, 2024 to Aug 31, 2024
    • Study completion date: Jun 30, 2024 to Jun 30, 2026
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Eligibility criteria expanded, about 104 wordsv4
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  1. Start date changed from estimate of May 1, 2021 to May 10, 2021v3
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
Trial Details
NCT Number NCT04870346
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)		 Aplastic Anemia
Related terms Anemia, Aplastic
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov