Phase 2 N=15 Treatment

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

Cystic Fibrosis · Exocrine Pancreatic Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT00743483 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Nov 2014

Primary outcome: Primary: The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA) — 6.9 % CFA — p=0.2179

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rhBSSL (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Swedish Orphan Biovitrum
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)	6.9	0.2179

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.