SWEDISH ORPHAN BIOVITRUM

🇫🇷France

Country: 🇫🇷France

Ownership: -

Established: 2010-01-01

Employees: -

Market Cap: $10.7B

Website: http://www.sobi.com/

Clinical Trials

Taste and Palatability of Orfadin Suspension

Phase 1

Completed

Conditions: Hereditary Tyrosinemia, Type I

Interventions: Drug: Nitisinone

First Posted Date: 2012-11-28

Last Posted Date: 2014-11-06

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 18

Registration Number: NCT01734889

Locations: 🇩🇪
Klinikum der Universität München, München, Germany
🇫🇷
Hopital Necker, Paris, France
🇩🇪
Universitätsklinikum Düsseldorf, Düsseldorf, Germany

and more 4 locations

Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Nitisinone, capsule
Drug: Nitisinone, suspension

First Posted Date: 2012-09-11

Last Posted Date: 2014-03-17

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 12

Registration Number: NCT01682538

Locations: 🇳🇱
Pharmaceutical Research Associates Group B.V (PRA), Zuidlaren, Netherlands

First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: NI-0501
Drug: Placebo

First Posted Date: 2011-10-25

Last Posted Date: 2023-08-09

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 20

Registration Number: NCT01459562

Locations: 🇬🇧
HMR, London, United Kingdom
🇬🇧
ICON, Manchester, United Kingdom

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: Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)
Drug: Placebo

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

Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

Phase 1

Completed

Conditions: Focus: Bioavailability

Interventions: Drug: Vitamin B12-ratiopharm N, injection solution
Drug: Nascobal nasal spray (cyanocobalamin, USP)

First Posted Date: 2011-03-01

Last Posted Date: 2014-11-02

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 16

Registration Number: NCT01306123

Locations: 🇸🇪
Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Stockholm, Sweden

Study to Characterize the Effect of Heparin on Palifermin Activity

Phase 1

Completed

Conditions: Oral Mucositis

Interventions: Drug: Palifermin
Drug: Heparin

First Posted Date: 2010-07-15

Last Posted Date: 2014-11-06

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 44

Registration Number: NCT01163097

Locations: 🇺🇸
New Orleans Center for Clinical Research (NOCCR), Knoxville, Tennessee, United States

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

Phase 2

Completed

Conditions: Cystic Fibrosis
Exocrine Pancreatic Insufficiency

Interventions: Drug: rhBSSL

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
Drug: rhBSSL

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
Drug: rhBSSL

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

A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Phase 1

Completed

Conditions: Mucositis
Head and Neck Cancer

Interventions: Drug: Placebo
Drug: palifermin
Radiation: Radiotherapy
Drug: Cisplatin

First Posted Date: 2008-02-29

Last Posted Date: 2017-06-21

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 5

Registration Number: NCT00626639

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