Clinical trials: sponsored by CSL Behring
Aneurysmatic Subarachnoid Haemorrhage
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of…
- Trial name
- NCT02540005
- Testing
- ROTEM analysis
- Where
- Finland
- Volunteers
- 32 people
- Sponsor
- Tampere University Hospital
Thrombosis
Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra
Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Trial name
- 4PAR (NCT02270918)
- Testing
- Kcentra, Apixaban
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Systemic Sclerosis
CSL Behring Sclero XIII
Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels, mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon (fingers or toes turning white then blue in the cold)…
- Trial name
- NCT02551042
- Testing
- Fibrogammin®P, coagulation factor XIII concentrate (Human), 0.9% sodium chloride
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- University College, London
Drug Action Reversal
Reversal of Dabigatran With Prothrombin Complex Concentrate
The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified skin-bleeding tests.
- Trial name
- NCT02463591
- Testing
- Beriplex
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Hemophilia B
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
- Trial name
- NCT01496274
- Testing
- rIX-FP
- Where
- 30 sites in United States, Austria and 8 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Hemophilia B
A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B
This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor…
- Trial name
- NCT01361126
- Testing
- Recombinant Coagulation Factor IX Albumin Fusion Protein
- Where
- 2 sites in Bulgaria, Israel
- Volunteers
- 17 people
- Sponsor
- CSL Behring
Hemophilia B
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
- Trial name
- NCT01662531
- Testing
- rIX-FP
- Where
- 17 sites in Australia, Austria and 8 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Hemophilia A, Hemophilia B
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia…
- Conditions
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- Trial name
- NCT01090206
- Testing
- Vitamin D and calcium
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Virginia Commonwealth University
Immune Thrombocytopenic Purpura
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. The primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with…
- Trial name
- NCT01390649
- Testing
- IgPro10
- Where
- 17 sites in Bulgaria, Romania and 1 more
- Volunteers
- 57 people
- Sponsor
- CSL Behring
Surgery
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.
- Trial name
- PBM (NCT01820949)
- Where
- 4 sites in Germany
- Volunteers
- 110,000 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Rabies
Rabies Immune Plasma Booster Study
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors.
- Trial name
- NCT01063140
- Testing
- Rabies Vaccine (RabAvert), Rabies Vaccine (Imovax)
- Where
- 10 sites in United States
- Volunteers
- 491 people, healthy volunteers welcome
- Sponsor
- CSL Behring
End Stage Renal Disease
Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation
The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor.
- Trial name
- NCT00784979
- Testing
- CMVIG
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Tampa General Hospital
Hereditary Angioedema
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities…
- Trial name
- NCT00292981
- Testing
- C1 Esterase Inhibitor
- Where
- 14 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- CSL Behring
Reversal of Coagulopathy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring
Hereditary Angioedema
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of…
- Trial name
- NCT00168103
- Testing
- C1 Esterase Inhibitor
- Where
- 36 sites in United States, Argentina and 13 more
- Volunteers
- 126 people
- Sponsor
- CSL Behring
Heart Disease
The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery
Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are…
- Trial name
- ZEPLAST (NCT01471730)
- Testing
- Fibrinogen, Saline solution, Prothrombin complex
- Where
- Italy
- Volunteers
- 119 people
- Sponsor
- IRCCS Policlinico S. Donato
Hemophilia A
Quality of Life Study of Helixate NexGen
The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen.
- Trial name
- NCT01053715
- Where
- 31 sites in Austria, Belgium and 5 more
- Volunteers
- 78 people
- Sponsor
- CSL Behring
Alpha1-proteinase Inhibitor Deficiency, Emphysema
Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency.
- Trial name
- NCT00261833
- Testing
- Alpha1-proteinase inhibitor
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 180 people
- Sponsor
- CSL Behring
Coagulopathic Bleeding
Open Label Use Of RiaStap During Aortic Reconstruction
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product…
- Trial name
- NCT01300286
- Testing
- RiaSTAP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Duke University