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Completed

NCT Number: NCT00743483

Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency

The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus Medical Center, Rotterdam, Netherlands

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About this study

In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools >= 5 times per week

Treatment and study plan

rhBSSL

Drug

oral suspension, 170 mg BSSL, 3 times daily for 5-6 days

Other names: BSSL, Bucelipase alfa, rhBSSL

Primary outcomes

  1. The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)

    Time frame: Final 3 days of baseline and treatment period

    The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.

    CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).

    Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.

    Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.

    The unit of CFA is %

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Nov 18, 2014

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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