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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004063-21-NL

Enrollment

Registered

2007-10-31

Start date

2008-07-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis and pancreatic insufficiency MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis

Interventions

Product Name: rhBSSL Product Code: rhBSSL Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Bucelipase alfa CAS Number: 9026-00-0 Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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. 11. Unwilling/unable to switch to esomeprazole 40 mg over the specified baseline and treatment periods. 12. Taking any drug incompatible with esomeprazole. 13. Liver failure. 14. Severe malnutrition defined as BMI < 18. 15. Any previous allergy to the investigational product and/or associated products. 16. Known history of hypersensitivity or intolerance to omeprazol or esomeprazole. 17. Known alcohol abuse. 18. On the waiting list for, or previously had lung transplantation. 19. Participation in another therapeutic clinical trial less than four weeks before inclusion in the study. 20. Not able or willing to comply with the study requirements for the duration of the study. 21. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of rhBSSL on the coefficient of fat absorption in patients with cystic fibrosis and pancreatic insufficiency, following administration of a fixed daily dose of rhBSSL.;Secondary Objective: To assess the safety and tolerability of multiple doses of BSSL;Primary end point(s): The primary endpoint of the study is the Coefficient of Fat Absorption (CFA), measured from stool collection during 72 h in baseline and treatment periods.	—

Measure

Time frame

Main Objective: To assess the effect of rhBSSL on the coefficient of fat absorption in patients with cystic fibrosis and pancreatic insufficiency, following administration of a fixed daily dose of rhBSSL.;Secondary Objective: To assess the safety and tolerability of multiple doses of BSSL;Primary end point(s): The primary endpoint of the study is the Coefficient of Fat Absorption (CFA), measured from stool collection during 72 h in baseline and treatment periods.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026