SWEDISH ORPHAN BIOVITRUM

🇫🇷France

Country: 🇫🇷France

Ownership: -

Established: 2010-01-01

Employees: -

Market Cap: $10.7B

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

Clinical Trials

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

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

Phase 1

Withdrawn

Conditions: Head and Neck Cancer

Interventions: Drug: Placebo
Drug: palifermin

First Posted Date: 2007-10-08

Last Posted Date: 2009-03-02

Lead Sponsor: Swedish Orphan Biovitrum

Registration Number: NCT00540332

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Palifermin
Radiation: Total Body irradiation
Drug: Chemotherapy

First Posted Date: 2007-04-16

Last Posted Date: 2014-12-05

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 27

Registration Number: NCT00460421

Locations: 🇺🇸
University of Texas, Dallas, Texas, United States
🇺🇸
Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Loma Linda University, Loma Linda, California, United States

and more 4 locations

Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain

Phase 2

Completed

Conditions: Diabetic Neuropathic Pain

Interventions: Drug: Placebo
Drug: BVT.115959

First Posted Date: 2007-03-27

Last Posted Date: 2014-11-02

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 193

Registration Number: NCT00452777

Locations: 🇿🇦
Biovitrum Investigational Site, Wynberg, South Africa
🇨🇿
Biovitrum investigational site, Praha 8, Czech Republic

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Palifermin before only
Drug: Palifermin before and after
Drug: Placebo

First Posted Date: 2007-02-12

Last Posted Date: 2015-03-30

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 281

Registration Number: NCT00434161

Locations: 🇩🇪
Universitatsklinikum Leipzig, Leipzig, Germany

Palifermin DDI (Drug Drug Interaction)

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Palifermin
Drug: Heparin

First Posted Date: 2006-08-08

Last Posted Date: 2014-11-06

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 45

Registration Number: NCT00361348

PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

Phase 4

Completed

Conditions: Non-Hodgkin's Lymphoma
Multiple Myeloma

Interventions: Drug: Kepivance (Palifermin)

First Posted Date: 2006-07-17

Last Posted Date: 2014-11-02

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 145

Registration Number: NCT00352703

Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation

Phase 2

Completed

Conditions: Graft Versus Host Disease
Hematologic Malignancies

Interventions: Drug: Placebo
Drug: Palifermin
Other: Conditioning Regimen
Procedure: Allogeneic stem cell transplant
Drug: Methotrexate

First Posted Date: 2005-09-19

Last Posted Date: 2014-09-15

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 155

Registration Number: NCT00189488

Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Phase 3

Completed

Conditions: Cancer
Leukemia
Lymphoma

Interventions: Drug: palifermin
Radiation: Total Body Irradiation
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Placebo

First Posted Date: 2005-04-25

Last Posted Date: 2014-09-15

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 47

Registration Number: NCT00109031

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Phase 3

Completed

Conditions: Head and Neck Cancer
Solid Tumors
Mucositis
Stomatitis
Squamous Cell Carcinoma

Interventions: Drug: palifermin
Drug: Placebo
Drug: cisplatin chemotherapy
Radiation: Radiotherapy

First Posted Date: 2005-01-13

Last Posted Date: 2016-09-27

Lead Sponsor: Swedish Orphan Biovitrum

Target Recruit Count: 188

Registration Number: NCT00101582

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