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A Three-month, Open-Label, Randomized, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VAL-1221 versus Myozyme/Lumizyme in Patients with Late-Onset GSD-II (Pompe Disease) Followed by Open-Label Treatment with VAL-1221 in all Patients

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A Three-month, Open-Label, Randomized, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VAL-1221 versus Myozyme/Lumizyme in Patients with Late-Onset GSD-II (Pompe Disease) Followed by Open-Label Treatment with VAL-1221 in all Patients

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Clervonafusp alfa (Primary) ; Alglucosidase alfa
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Valerion Therapeutics

    • Most Recent Events

    • 29 May 2020 Status changed from active, no longer recruiting to discontinued.
    • 22 Apr 2020 This trial has been discontinued in United Kingdom, according to European Clinical Trials Database record.
    • 04 Sep 2019 Planned End Date changed from 1 Jun 2019 to 1 Jun 2020.

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