An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A

Biovitrum AB0 sites18 target enrollmentOctober 31, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male and female patients age \= 18 years.
•2\. Women of childbearing potential must use proper methods of birth control during study, mechanical or hormonal.
•3\. Clinically diagnosed CF established by sweat test or positive genotyping for two disease causing CF mutations of class I and II transmembrane conductance regulator (CFTR).
•4\. Documented PI by fecal elastase\-1 monoclonal test \<100 µg/g.
•5\. Able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days.
•6\. Able to produce stools \= 5 times per week.
•7\. Able to give signed written informed consent to participate in this study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Women who are pregnant or breast feeding.
•2\. Short bowel or other complications related to previous gastrointestinal (GI) surgery.
•3\. Continuous enteric feeding by PEG or by enteral tube.
•4\. Intravenous nutrition within two weeks before inclusion in the study.
•5\. Acute antibiotic treatment within two weeks of inclusion in study (maintenance antibiotic treatment allowed).
•6\. Known Distal Intestinal Obstructive Syndrome (DIOS).
•7\. Treatment with prokinetics during the course of the study.
•8\. Any intake of alcohol 10 hours prior to screening.
•9\. Unstable diabetes.
•10\. FEV1 \< 40%, and/or unstable lung disease, such as recent exacerbations, within last 4 months.