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Completed

NCT Number: NCT02734810

SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

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Key information

Conditions

Exocrine Pancreatic Insufficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

28 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 139, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For Part A: males or females ≥7 years of age
  • For Part B: males or females 28 days to <7 years
  • Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
  • Low fecal elastase
  • Fair-to-good nutritional status

Exclusion criteria

  • History or diagnosis of fibrosing colonopathy
  • Distal intestinal obstruction syndrome in 6 months prior to screening
  • Receiving enteral tube feedings
  • Chronic diarrheal illness unrelated to pancreatic insufficiency
  • Liver abnormalities, or liver or lung transplant, or significant bowel resection

Treatment and study plan

Liprotamase Powder for Oral Solution

Drug

Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Other names: Liprotamase

Primary outcomes

  1. Safety

    Time frame: 1 week

    Number of subjects reporting 1 or more adverse events

Sponsors and collaborators

Lead sponsor

Anthera Pharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Acronym: SIMPLICITY

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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