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the Application of an Electronic Nose in the Early detection of Aspergillosis II

1. To establish whether serial exhaled breath analysis using eNose can detect invasive pulmonary aspergillosis in patients with prolonged chemotherapy induced neutropenia (neutrophil counts <0.5 x 10^9 for more than 7 days).2. To establish…

A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients.

The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.

A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…

A Phase 3b Clinical Study To Assess Whether Regular Administration Of Advate In The Absence Of Immunological Danger Signals Reduces The Incidence Rate Of Inhibitors In Previously Untreated Patients With Hemophilia A

Primary objective:Determine the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A during the first 50 exposure days (EDs) to starting with a once weekly prophylactic regimen together with the minimization…

Randomized, open label, multicenter phase III study of Efficacy and Safety in POlycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK iNhibitor INC424 tablets verSus bEst available care

Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…

Effect of increasing low serum hemoglobin level on functional recovery after hip fracture surgery in the elderly. A prospective randomized clinical trial.

To assess whether increasing low hemoglobin levels to near normal accelerate functional recovery and shorten the revalidation period after hip fracture surgery in the elderly.

the Application of an Electronic Nose in the Early detection of ASpergillosis

to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls

A randomized, open label, multicentre trial to define the most effective haemoglobin concentration to start erythropoietin beta (neoRecormon) therapy in anaemic subjects with lymphoproliferative malignancy receiving chemotherapy
*REPOS Study*

To compare the efficacy of erythropoietin beta administered weekly using an early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb * 6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving chemotherapy during a 16-…

Enteral versus parenteral feeding in adult stem cell transplantation patients with chemotherapy-induced gastro-intestinal mucositis.

In this study, we will test which of two feeding strategies for adults during chemotherapy-induced mucositis is optimal with regards to maintaining an optimal body weight, nutritional status, gut mucosal barrier and treatment outcome (including…

In vivo measurement of lymphocyte kinetics during immune reconstitution after hematopoietic stem cell transplantation using [6,6-2H2]-glucose labeling

To get more insight into lymphocyte kinetics during immune reconstitution after hematopoietic stem cell transplantation

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz 112638 in Patients with Gaucher Disease Type 1 who have been Stabilized with Cerezyme

The primary objective of this study is to assess the efficacy and safety of Genz-112638 compared with Cerezyme after 52 weeks of treatment in patients with Gaucher disease type 1 who have been stabilized with Cerezyme. The secondary objective of…

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician*s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

Primary:• To compare the overall survival (OS) of patients in the rigosertib group vs the Physician*s Choice group, in all patients and in a subgroup of patients with IPSS-R very high riskSecondary efficacy• To compare rigosertib to Physician*s…

Cerebrovascular reserve and white matter disease in patients with chronic anemia. (IMPROvE)

Primary Objective: The main goal of this project is to identify CVR predictors including CBF, age, sex and vascular stressors in anaemic and control patients using several MRI techniques. While anaemia is correlated with other cerebrovascular risk…

A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare
T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

To assess the rate of complete response (CR) in Grades III and IV SR-aGVHD participants on Day 28 postrandomization.

A randomized, double-blind, three-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single 6 mg subcutaneous administration of the
proposed biosimilar product LA-EP2006, Neulasta® US and Neulasta® EU in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta®US and Neulasta®EU with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called…

Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial.

Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…

A Randomized, Double-blind, Active-controlled, Phase 3 study evaluating the Efficacy and Safety of ABP 959 compared with Eculizumab in Adult Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety,…

Multicenter randomized controlled trial comparing Ferric(III)carboxymaltose infusion with oral iron suppletion in the treatment of perioperative anemia in patients with a colorectal carcinoma.

The aim of this trial is to investigate which treatment option is superior in the treatment of anemia in patients undergoing surgery in terms of hemoglobin increase, postoperative morbidity, amount of bloodtransfusions needed, length of stay,…