drugset / Trial / NCT00659243

Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants

NCT00659243 ↗

Phase 2 Completed 32 enrolled Swedish Orphan Biovitrum
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Timeline

Start
2008-03
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject rhBSSL Protein / enzyme biologic 0.15 mg/ml —

Indications

No indication recorded.