SWEDISH ORPHAN BIOVITRUM

🇫🇷France

Country: 🇫🇷France

Ownership: -

Established: 2010-01-01

Employees: -

Market Cap: $10.7B

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

Clinical Trials

Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products

Completed

Conditions: Hemophilia A

Interventions: Drug: Factor VIII
Drug: efmoroctocog alfa

First Posted Date: 2016-11-29

Last Posted Date: 2024-10-02

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 361

Registration Number: NCT02976753

Locations: 🇮🇹
Swedish Orphan Biovitrum Research Site, Padova, Italy
🇬🇧
Swedish Orphan Biovitrum Reserach site, London, United Kingdom
🇪🇸
Swedish Orphan Biovitrum research site, Alicante, Spain

and more 1 locations

Kineret in the Treatment of Rheumatoid Arthritis

Completed

Conditions: Rheumatoid Arthritis

First Posted Date: 2016-09-26

Last Posted Date: 2017-08-11

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 30

Registration Number: NCT02915094

Locations: 🇩🇪
Swedish Orphan Biovitrum Investigational Site, Freiburg, Germany

Kineret CAPS Post Authorisation Study

Completed

Conditions: Cryopyrin-Associated Periodic Syndromes

Interventions: Drug: anakinra (Kineret)

First Posted Date: 2014-12-29

Last Posted Date: 2020-01-18

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 12

Registration Number: NCT02326376

Locations: 🇬🇧
Swedish Orphan Biovitrum Investigational Site, London, United Kingdom

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1

Phase 3

Completed

Conditions: Hereditary Tyrosinemia, Type I

Interventions: Drug: Nitisinone

First Posted Date: 2014-12-23

Last Posted Date: 2015-11-11

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 18

Registration Number: NCT02323529

Locations: 🇸🇪
Swedish Orphan Biovitrum Investigational site, Gothenburg, Sweden
🇩🇪
Swedish Orphan Biovitrum Investigational Site, Reutlingen, Germany

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

Completed

Conditions: Hereditary Tyrosinemia, Type I

Interventions: Drug: Nitisinone

First Posted Date: 2014-12-19

Last Posted Date: 2020-01-14

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 315

Registration Number: NCT02320084

Locations: 🇬🇧
Swedish Orphan Biovitrum Investigational Site, Sheffield, United Kingdom
🇬🇧
Swedish Oprhan Biovitrum Investigational Site, Manchester, United Kingdom

Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: SOBI002
Drug: Placebo

First Posted Date: 2014-03-11

Last Posted Date: 2015-07-28

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 24

Registration Number: NCT02083666

Locations: 🇬🇧
Richmond Pharmacology Ltd., London, St George's University of London, United Kingdom

A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody

Phase 2

Completed

Conditions: Hemophagocytic Lymphohistiocytosis

Interventions: Drug: Emapalumab

First Posted Date: 2014-02-24

Last Posted Date: 2022-06-28

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 58

Registration Number: NCT02069899

Locations: 🇬🇧
Great Ormond Street Hospital - Department of Haematology, London, United Kingdom
🇮🇹
Azienda Ospedaliera Padova, Padova, Italy
🇮🇹
Ospedale della Donna e del Bambino - U.O.C. Oncoematologia Pediatrica, Verona, Italy

and more 13 locations

A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

Completed

Conditions: Haemophilia A
Haemophilia B

First Posted Date: 2014-01-29

Last Posted Date: 2016-03-14

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 1658

Registration Number: NCT02049099

Locations: 🇸🇪
Swedish Orphan Biovitrum Investigational Site, Stockholm, Sweden
🇬🇧
UKHCDO, Manchester, United Kingdom

Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Nitisinone 10 mg
Drug: Nitisinone 20 mg

First Posted Date: 2013-05-20

Last Posted Date: 2021-10-12

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 12

Registration Number: NCT01857362

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

Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

Phase 2

Completed

Conditions: Primary Haemophagocytic Lymphohistiocytosis

Interventions: Biological: NI-0501

First Posted Date: 2013-03-26

Last Posted Date: 2023-02-21

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 45

Registration Number: NCT01818492

Locations: 🇬🇧
Great Ormond Street Hospital - Department of Haematology, London, United Kingdom
🇸🇪
Karolinska University Hospital, Stockholm, Sweden
🇮🇹
Ospedale Pediatrico Bambino Gesu', Roma, Italy

and more 17 locations

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