Clinical trials: sponsored by Swedish Orphan Biovitrum
Chronic Gout
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo.
- Trial name
- DISSOLVE II (NCT04596540)
- Testing
- SEL-212 low-dose, SEL-212 high-dose
- Where
- 53 sites in United States, Georgia and 3 more
- Volunteers
- 153 people
- Sponsor
- Swedish Orphan Biovitrum
Macrophage Activation Syndrome (MAS), Still Disease, Juvenile Onset
Assessment of Macrophage Activation syndromE in STill's Disease in Italy
Assessment of macrophage activation syndrome in Still's disease: retrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy
- Conditions
- Macrophage Activation Syndrome (MAS), Still Disease, Juvenile Onset, Still's Disease, Adult-Onset
- Trial name
- AMETISTA (NCT06992505)
- Where
- 2 sites in Italy
- Volunteers
- 32 people
- Sponsor
- Swedish Orphan Biovitrum
Transplant-Associated Thrombotic Microangiopathy
A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation
The purpose of the study was to assess pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of pegcetacoplan in patients with TA-TMA after HSCT.
- Trial name
- NCT05148299
- Testing
- Pegcetacoplan
- Where
- 14 sites in United States, France and 3 more
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Cold Agglutinin Disease
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin…
- Trial name
- NCT05096403
- Testing
- Pegcetacoplan
- Where
- 44 sites in United States, Austria and 12 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia B
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic…
- Trial name
- B-MORE (NCT03901755)
- Testing
- Alprolix
- Where
- 29 sites in Czechia, Greece and 7 more
- Volunteers
- 151 people
- Sponsor
- Swedish Orphan Biovitrum
Chronic Gout
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo.
- Trial name
- DISSOLVE I (NCT04513366)
- Testing
- SEL-212 low-dose, SEL-212 high-dose, Normal Saline
- Where
- 40 sites in United States
- Volunteers
- 112 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenia, ITP
An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge…
- Trial name
- ADOPT (NCT04943042)
- Testing
- Avatrombopag
- Where
- 55 sites in Croatia, Czechia and 7 more
- Volunteers
- 199 people
- Sponsor
- Swedish Orphan Biovitrum
Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis [SJIA] and Adult-onset Still's disease [AOSD]).
- Trial name
- NCT05814159
- Testing
- Anakinra
- Where
- 8 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A, Hemophilia B
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.
- Trial name
- JOIN-us (NCT05856266)
- Testing
- Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US), Haemophilia Joint Health Score (HJHS)
- Where
- 56 sites in Bulgaria, Croatia and 9 more
- Volunteers
- 10 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period.
- Trial name
- NCT02976753
- Testing
- efmoroctocog alfa, Factor VIII
- Where
- 36 sites in Austria, Belgium and 7 more
- Volunteers
- 361 people
- Sponsor
- Swedish Orphan Biovitrum
Haemophilia A, Haemophilia B
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in…
- Trial name
- PREVENT (NCT03055611)
- Testing
- ELOCTA, ALPROLIX
- Where
- 22 sites in Germany
- Volunteers
- 201 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies
The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at…
- Trial name
- ReITIrate (NCT03103542)
- Testing
- Recombinant coagulation factor (rFVIIIFc)
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 16 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.
- Trial name
- A-MOVE (NCT04133883)
- Testing
- Ultrasound, Haemophilia Joint Health Score
- Where
- 20 sites in France
- Volunteers
- 88 people
- Sponsor
- Swedish Orphan Biovitrum
Haemophilia B
A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic…
- Trial name
- B-SURE (NCT03655340)
- Testing
- Alprolix
- Where
- 18 sites in France
- Volunteers
- 91 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A With Inhibitor
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.
- Trial name
- NCT03951103
- Testing
- rFVIIIFc
- Where
- 18 sites in France, Germany and 6 more
- Volunteers
- 44 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophagocytic Lymphohistiocytosis
Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
This observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.
- Trial name
- NCT03259230
- Testing
- Blood Draws, Data Collection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Swedish Orphan Biovitrum
Still Disease, Juvenile Onset
Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA).
- Trial name
- NCT03932344
- Testing
- Anakinra
- Where
- Italy
- Volunteers
- 306 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A, Hemophilia B
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.
- Trial name
- Hemo-FAST (NCT04731701)
- Testing
- Hemophilia Joint Health Score (HJHS)
- Where
- 16 sites in France
- Volunteers
- 180 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophagocytic Lymphohistiocytoses
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to…
- Trial name
- NCT06047210
- Testing
- Blood Draws Data Collection
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Swedish Orphan Biovitrum
Hereditary Tyrosinemia, Type I
Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care
The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1).
- Trial name
- OPAL (NCT02320084)
- Testing
- Nitisinone
- Where
- 77 sites in Austria, Belgium and 15 more
- Volunteers
- 315 people
- Sponsor
- Swedish Orphan Biovitrum