Clinical trials: sponsored by 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
Healthy Volunteers
Palifermin DDI (Drug Drug Interaction)
The purpose of this study is to determine if Paliferim interacts with Heparin.
- Trial name
- NCT00361348
- Testing
- Palifermin, Heparin
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
- Trial name
- NCT00659243
- Testing
- rhBSSL
- Where
- 8 sites in France, Italy
- Volunteers
- 32 people
- Sponsor
- Swedish Orphan Biovitrum
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
- Trial name
- NCT00658905
- Testing
- rhBSSL
- Where
- 6 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Non-Hodgkin's Lymphoma, Multiple Myeloma
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and…
- Trial name
- NCT00352703
- Testing
- Kepivance (Palifermin)
- Volunteers
- 145 people
- Sponsor
- Swedish Orphan Biovitrum
Diabetic Neuropathic Pain
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.
- Trial name
- NCT00452777
- Testing
- BVT.115959
- Where
- 20 sites in Czechia, Germany and 1 more
- Volunteers
- 193 people
- Sponsor
- Swedish Orphan Biovitrum
Focus: Bioavailability
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
- Trial name
- NCT01306123
- Testing
- Nascobal nasal spray (cyanocobalamin, USP), Vitamin B12-ratiopharm N, injection solution
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Leukemia, Lymphoma
Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support.
- Conditions
- Leukemia, Lymphoma, Myeloma
- Trial name
- NCT00070616
- Testing
- Palifermin 6 x 60 μg/kg/day, Palifermin 2 x 180 μg/kg/day, radiotherapy
- Volunteers
- 25 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
Juvenile Chronic Arthritis
Juvenile Rheumatoid Arthritis
The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.
- Trial name
- NCT00037648
- Testing
- Anakinra
- Volunteers
- 86 people
- Sponsor
- Amgen
Rheumatoid Arthritis
The SPECTRA Study
The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid…
- Trial name
- NCT00537667
- Testing
- anakinra, anakinra and PEG sTNF-R1
- Volunteers
- 22 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis
The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis.
- Trial name
- NCT00037700
- Testing
- anakinra, pegsunercept
- Sponsor
- Amgen
Rheumatoid Arthritis
Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire
The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringe(s) when using Kineret® in RA subjects.
- Trial name
- NCT00121043
- Testing
- SimpleJectTM, Kineret® (Anakinra)
- Sponsor
- Amgen
Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
- Trial name
- NCT00540332
- Testing
- palifermin
- Sponsor
- Swedish Orphan Biovitrum