RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

• IRAS ID

  226061

• Contact name

  Mary Carroll

• Contact email

  Mary.Carroll@uhs.nhs.uk

• Sponsor organisation

  Anthera Pharmaceuticals, Inc.

• Eudract number

  2017-000571-85

• Clinicaltrials.gov Identifier

  NCT03051490

• Clinicaltrials.gov Identifier

  062,037, BB-IND number

• Duration of Study in the UK

  0 years, 11 months, 29 days

• Research summary

  This is a Phase 3, 2-group, parallel, randomized, open-label,
  assessor-blind, non-inferiority study comparing the non-porcine
  enzyme product, liprotamase, to Pancreaze in subjects ≥7 years of age
  with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  17/SC/0271

• Date of REC Opinion

  19 Sep 2017

• REC opinion

  Further Information Favourable Opinion