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OpenTrials
Completed

NCT Number: NCT02823964

EASY: Extended Access to Sollpura Over Years

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.

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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

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigator Site 501, Brno, Czechia

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About this study

The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)

Exclusion criteria

  • Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
  • Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Treatment and study plan

Liprotamase

Drug

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

Other names: Sollpura

Primary outcomes

  1. Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities

    Time frame: 12 months

    Descriptive analysis

Sponsors and collaborators

Lead sponsor

Anthera Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
May 17, 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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