This study is currently not recruiting participants.

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

Investigating Treatment Effects on Digestive Enzyme Function in Cystic Fibrosis Patients

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to demonstrate the non-inferiority of liprotamase to the active comparator for the change in coefficient of fat absorption from screening to the end of the treatment period in subjects > or = 7 years of age with EPI due to cystic fibrosis.

Detailed description of study

The purpose of this study is to demonstrate the non-inferiority of liprotamase to the active comparator for the change in coefficient of fat absorption from screening to the end of the treatment period in subjects > or = 7 years of age with EPI due to cystic fibrosis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cystic fibrosis
  • Age: 100 years or below
  • Gender: All

This study investigates the effectiveness of an investigational medication compared to an active treatment in improving fat absorption in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis. Exocrine pancreatic insufficiency is a condition where the pancreas does not produce enough enzymes to properly digest food, leading to poor absorption of nutrients.

Participants will receive either the investigational medication or the active comparator, and their fat absorption will be measured from the start to the end of the treatment period. This will help determine if the investigational medication is as effective as the current treatment.

  • Who can participate: Individuals aged 7 years and older with exocrine pancreatic insufficiency due to cystic fibrosis are eligible to participate.
  • Study details: Participants will be assigned to receive either the investigational medication or an active comparator. Their fat absorption levels will be monitored throughout the study period.
Updated on 19 Feb 2024. Study ID: 1510435361

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