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A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics, Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment

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Trial Profile

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics, Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs Apadamtase alfa (Primary)
  • Indications Thrombotic thrombocytopenic purpura
  • Focus Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Acronyms SOAR-HI
  • Sponsors Baxalta; Baxalta Innovations GmbH; Shire; Takeda

Most Recent Events

  • 05 Nov 2023 This trial has been completed in Italy according to European Clinical Trials Database record.
  • 15 Jun 2023 Results assessing pharmacokinetic (PK) characteristics of ADAMTS13 in patients with iTTP receiving treatment for an acute TTP episode, the PK/pharmacodynamic (PD) relationship between ADAMTS13 activity levels and biomarkers, and safety presented at the 28th Congress of the European Haematology Association.
  • 18 Feb 2022 Status changed from active, no longer recruiting to completed.

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