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A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents

Trial Profile

A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Luspatercept (Primary)
  • Indications Alpha-thalassaemia; Anaemia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Celgene Corporation

Most Recent Events

  • 17 Dec 2024 Planned End Date changed from 18 Jun 2026 to 14 Aug 2034.
  • 17 Dec 2024 Planned primary completion date changed from 5 Nov 2025 to 16 Jul 2027.
  • 23 Feb 2024 According to ClinicalTrials.gov record, protocol has been amended to increase patient number from 177 to 249. Also the primary endpoints are changed and the overall trial focus has been updated as AR, TU, PK.

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