drugset

drugset / Trial / NCT00743483

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

NCT00743483 ↗

Phase 2 Completed 15 enrolled Swedish Orphan Biovitrum

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2008-08
Primary completion: 2009-06
Completion: 2009-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); rhBSSL; p = 0.2179; t-test, 2 sided NCT00743483 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rhBSSL	Protein / enzyme biologic	170 mg	Oral

Indications