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A Phase IIa Study to Investigate Safety, Pharmacokinetics, and Efficacy of Odiparcil in Patients 16 Years and Above With Mucopolysaccharidosis (MPS) Type VI

Trial Profile

A Phase IIa Study to Investigate Safety, Pharmacokinetics, and Efficacy of Odiparcil in Patients 16 Years and Above With Mucopolysaccharidosis (MPS) Type VI

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Odiparcil (Primary)
  • Indications Mucopolysaccharidosis VI
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Acronyms iMProveS
  • Sponsors Inventiva Pharma
  • Most Recent Events

    • 31 Oct 2019 Status changed from active, no longer recruiting to completed.
    • 11 Jun 2019 According to an Inventiva Pharma media release, company plans to amend the study protocol to update the target patient population to 20 subjects.
    • 11 Jun 2019 According to an Inventiva Pharma media release, headline results of the double-blind placebo controlled arms, which include the fifteen ERT-treated patients, are expected by the end of the year. Results of the open label cohort, which includes the five patients not being treated with ERT and only receiving the high dose of odiparcil, are expected during Q1 2020 given that the last patient for this subgroup was included in May 2019.
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