Clinical trials: sponsored by Swedish Orphan Biovitrum
Healthy
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
- Trial name
- NCT01857362
- Testing
- Nitisinone 20 mg, Nitisinone 10 mg
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Still's Disease, Adult-Onset, Still's Disease, Juvenile-Onset
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic…
- Trial name
- anaSTILLs (NCT03265132)
- Testing
- anakinra
- Where
- 39 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Swedish Orphan Biovitrum
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
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
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
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL
- Trial name
- NCT00743483
- Testing
- rhBSSL
- Where
- 4 sites in Netherlands, Poland
- Volunteers
- 15 people
- Sponsor
- Swedish Orphan Biovitrum
Oral Mucositis
Study to Characterize the Effect of Heparin on Palifermin Activity
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
- Trial name
- NCT01163097
- Testing
- Palifermin, Heparin
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Hereditary Tyrosinemia, Type I
Taste and Palatability of Orfadin Suspension
The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.
- Trial name
- NCT01734889
- Testing
- Nitisinone
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 18 people
- Sponsor
- Swedish Orphan Biovitrum
Graft Versus Host Disease, Hematologic Malignancies
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
The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.
- Trial name
- NCT00189488
- Testing
- Palifermin, Conditioning Regimen, Allogeneic stem cell transplant
- Volunteers
- 155 people
- Sponsor
- Swedish Orphan Biovitrum
Cancer, Lymphoma
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).
- Conditions
- Cancer, Lymphoma, Leukemia
- Trial name
- NCT00109031
- Testing
- palifermin, Total Body Irradiation, Cyclophosphamide
- Volunteers
- 47 people
- Sponsor
- Swedish Orphan Biovitrum
Healthy Volunteers
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation.
- Trial name
- NCT01682538
- Testing
- Nitisinone, capsule, Nitisinone, suspension
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum