Clinical trials: sponsored by Swedish Orphan Biovitrum
Hemophilia B
Phase I/IIa Study of FIXFc in Hemophilia B Patients
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
- Trial name
- NCT00716716
- Testing
- rFIXFc
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bioverativ Therapeutics Inc.
Severe Hemophilia A
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at…
- Trial name
- Elevate (NCT02502149)
- Testing
- rFVIIIFc
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ Therapeutics Inc.
Hemophilia B
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B.
- Trial name
- Kids B-LONG (NCT01440946)
- Testing
- rFIXFc, FIX
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Bioverativ Therapeutics Inc.
Severe Hemophilia B
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy…
- Trial name
- NCT01027364
- Testing
- Factor IX (rFIXFc), rFIX
- Where
- 51 sites in United States, Australia and 15 more
- Volunteers
- 123 people
- Sponsor
- Bioverativ Therapeutics Inc.
Hemophilia A, Hemophilia B
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by…
- Trial name
- FORWARD (NCT02392156)
- Testing
- rFVIIIFc, rFIXFc, non-Fc FVIII replacement products
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Bioverativ Therapeutics Inc.
Acute Gouty Arthritis
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine.
- Trial name
- anaGO (NCT03002974)
- Testing
- Anakinra 100 mg, Triamcinolone Acetonide 40 mg
- Where
- 37 sites in United States
- Volunteers
- 165 people
- Sponsor
- Swedish Orphan Biovitrum
Cryopyrin-Associated Periodic Syndromes
Kineret CAPS Post Authorisation Study
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies…
- Trial name
- NCT02326376
- Testing
- anakinra (Kineret)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenic Purpura
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.
- Trial name
- NCT00718692
- Testing
- Sym001
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 61 people
- Sponsor
- Symphogen A/S
Rheumatoid Arthritis
Kineret in the Treatment of Rheumatoid Arthritis
Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials.
- Trial name
- NCT02915094
- Testing
- Anakinra
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Swedish Orphan Biovitrum
Drug Drug Interaction
A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers
An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion transporters OAT1 and OAT3 in healthy…
- Trial name
- NCT03103568
- Testing
- Nitisinone in Arm A, Tolbutamide, Metoprolol
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Mucositis, Head and Neck Cancer
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
Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting
- Trial name
- NCT00626639
- Testing
- palifermin, Radiotherapy, Cisplatin
- Volunteers
- 5 people
- Sponsor
- Swedish Orphan Biovitrum
Dysphagia, Non-Small Cell Lung Cancer
Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III…
- Conditions
- Dysphagia, Non-Small Cell Lung Cancer, Lung Cancer
- Trial name
- NCT00094861
- Testing
- Palifermin, Radiotherapy, Paclitaxel
- Volunteers
- 100 people
- Sponsor
- Swedish Orphan Biovitrum
Mucositis, Solid Tumors
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity…
- Conditions
- Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer
- Trial name
- NCT00101582
- Testing
- palifermin, cisplatin chemotherapy, Radiotherapy
- Volunteers
- 188 people
- Sponsor
- Swedish Orphan Biovitrum
Rheumatoid Arthritis
Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)
The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on the development of an anti-tetanus antibody response in subjects with RA after vaccination with a tetanus and diphtheria toxoids…
- Trial name
- NCT00111410
- Testing
- Anakinra (r-metHuIL-1ra)
- Sponsor
- Amgen
Haemophilia A, Haemophilia B
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
- Trial name
- NCT02049099
- Where
- 12 sites in Belgium, France and 5 more
- Volunteers
- 1,658 people
- Sponsor
- Swedish Orphan Biovitrum
Hereditary Tyrosinemia, Type I
Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1
The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.
- Trial name
- HT-1 (NCT02323529)
- Testing
- Nitisinone
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 18 people
- Sponsor
- Swedish Orphan Biovitrum
Prevention of Growth Restriction
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
- Trial name
- LAIF (NCT01413581)
- Testing
- rhBSSL (recombinant human bile-salt-stimulated lipase)
- Where
- 49 sites in Belgium, Czechia and 8 more
- Volunteers
- 415 people
- Sponsor
- Swedish Orphan Biovitrum
Healthy
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
- Trial name
- NCT02083666
- Testing
- SOBI002
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Multiple Myeloma
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell…
- Trial name
- NCT00434161
- Testing
- Palifermin before only, Palifermin before and after
- Where
- Germany
- Volunteers
- 281 people
- Sponsor
- Swedish Orphan Biovitrum
Leukemia
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation [TBI]) followed by hematopoietic stem cell…
- Trial name
- NCT00460421
- Testing
- Palifermin, Total Body irradiation, Chemotherapy
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Swedish Orphan Biovitrum