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
Phase of Trial: Phase I/II
Latest Information Update: 10 Jun 2016
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At a glance
- Drugs Burlulipase (Primary)
- Indications Cystic fibrosis; Exocrine pancreatic insufficiency
- Focus Proof of concept; Therapeutic Use
- Sponsors Nordmark Arzneimittel
- 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
- 02 Jun 2014 Planned End Date changed from 1 Apr 2014 to 1 Oct 2014 as reported by ClinicalTrials.gov record.