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Randomized, Open-label, Parallel-group, Multicenter, Non-inferiority and Dose-response Study to Evaluate the Efficacy and Safety of RYMPHYSIA (ARALAST NP) for Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema

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Trial Profile

Randomized, Open-label, Parallel-group, Multicenter, Non-inferiority and Dose-response Study to Evaluate the Efficacy and Safety of RYMPHYSIA (ARALAST NP) for Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema

Status: Withdrawn prior to enrolment
Phase of Trial: Phase IV

Latest Information Update: 09 May 2023

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At a glance

  • Drugs Alpha 1-antitrypsin (Primary)
  • Indications Chronic obstructive pulmonary disease; Emphysema
  • Focus Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 02 May 2023 Status changed from not yet recruiting to withdrawn prior to enrolment. (Business decision)
  • 08 Feb 2023 Planned initiation date changed from 16 Jan 2023 to 1 Jan 2024.
  • 07 Nov 2022 Planned number of patients changed from 168 to 214.

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