MedPath

Bucelipase alfa

Generic Name
Bucelipase alfa
Drug Type
Biotech
CAS Number
9026-00-0
Unique Ingredient Identifier
3C617U1K19
Background

Bucelipase alfa is under investigation in clinical trial NCT00743483 (Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency).

Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

Phase 3
Terminated
Conditions
Prevention of Growth Restriction
Interventions
First Posted Date
2011-08-10
Last Posted Date
2015-07-30
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
415
Registration Number
NCT01413581
Locations
🇸🇪

Swedish Orphan Biovitrum Investigational Site, Umeå, Sweden

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

Phase 2
Completed
Conditions
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Interventions
First Posted Date
2008-08-28
Last Posted Date
2014-11-18
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
15
Registration Number
NCT00743483
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

🇵🇱

Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Gdansku, Gdansk, Poland

🇵🇱

Uniwersytet Medyczny im. K. Marcinkowskiego, Poznan, Poland

and more 1 locations

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

Phase 2
Completed
Conditions
Replacement Therapy in Preterm Infants
Interventions
Drug: Placebo
First Posted Date
2008-04-16
Last Posted Date
2014-11-02
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
32
Registration Number
NCT00659243
Locations
🇫🇷

Hopital de la Croix Rousse, Lyon, France

🇫🇷

Maternité A. Pinard, Néonatologie, Nancy, France

🇫🇷

Hopital Saint Vincent de Paul, Paris, France

and more 5 locations

Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

Phase 2
Completed
Conditions
Replacement Therapy in Preterm Infants
Interventions
Drug: Placebo
First Posted Date
2008-04-16
Last Posted Date
2014-11-02
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
33
Registration Number
NCT00658905
Locations
🇮🇹

Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica, Rome, Italy

🇮🇹

Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale, Bari, Italy

🇮🇹

Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi, Ancona, Italy

and more 3 locations
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