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A multi-centre, randomized, double-blind, placebo-controlled phase 2 trial of pentosan polysulfate sodium in patients with MPS-VI

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Trial Profile

A multi-centre, randomized, double-blind, placebo-controlled phase 2 trial of pentosan polysulfate sodium in patients with MPS-VI

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Aug 2022

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At a glance

  • Drugs Pentosan polysulfate (Primary)
  • Indications Mucopolysaccharidosis VI
  • Focus Adverse reactions
  • Sponsors Paradigm Biopharma

Most Recent Events

  • 19 Aug 2022 New trial record
  • 12 Aug 2022 According to a Paradigm Biopharma media release, An additional safety review will be completed once 3 patients in this age group have been enrolled and reach the specified timepoint. A positive additional safety review will support the inclusion of subjects in the 5- to 9-year- old age group. These additional age groups are highly relevant to future potential therapeutic registration as the disease is detected and can manifest early in children and adolescents.
  • 12 Aug 2022 According to a Paradigm Biopharma media release, To date, three adult subjects have been enrolled in the study and fifty-two weeks of cumulative data across the subjects have been assessed. Under the clinical protocol, a mandated safety review has been completed with no serious adverse events reported. This is a key milestone for the phase 2 study, which now allows the inclusion of subjects aged 9 to 16 years to assess the safety and tolerability of PPS among paediatric populations.

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