A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Trial Profile

A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Jun 2016

At a glance

  • Drugs Burlulipase (Primary)
  • Indications Cystic fibrosis; Exocrine pancreatic insufficiency
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Nordmark Arzneimittel
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 10 Jun 2016 Primary endpoint of coefficient of fat absorption (CFA%) has been met, according to results published in the Journal of Pediatrics.
    • 10 Jun 2016 Results of phase IIa part of this study published in the Journal of Pediatrics
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