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Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study

To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage on live birth.

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

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…

The value of iron treatment for postoperative obstetric patients with anemia: a randomized double blind controlled trial

The purpose of this study will be to examine the effect of ferrous fumarate or ferinject in patients after a caesarean section with a hemoglobin level between 5.0. and 7.0 mmol/L.The primary outcome measure will be the hemoglobin level at 3 and 6…

Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.
A phase III randomized double-blind multi-center HOVON study.

Primary objective* To improve the response rate to treatment of severe steroid-refractory acute GvHD grade II-IV (with gut and/or liver involvement) by early addition of MSC to standardized second line treatmentSecondary objectives* To study the…

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The primary objective of this study is to evaluate the efficacy of roxadustat compared todarbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)subjects.The secondary objectives of this study are to:*…

A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.

Currently, caplacizumab is being developed for treatment of acquired thrombotic thrombocytopenic purpura (TTP). TTP is a rare and potentially life-threatening thrombotic microangiopathy, in which accumulation of ULvWF multimers leads to an increased…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

A Phase 1b, Randomized, Double-Blind (Sponsor Open), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-04447943, Co-Administered with and Without Hydroxyurea, in Subjects with Stable Sickle Cell Disease

Primary ObjectiveTo determine the safety and tolerability of multipledoses of PF-04447943 Secondary ObjectiveTo characterize the PK of PF-04447943 in plasma following oral administrationExploratory ObjectivesTo evaluate biomarkers that may be…

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.

Mitochondrial Oxygen Tension Improves not upon Fluid Administration but after Transfusion of Erythrocytes (MOTIFATE)
in chronic anemia patients
(a pilot study)

The study will compare the change in cutaneous cellular oxygen availability, measured as mitochondrial PO2 (mitoPO2) between a fluid challenge and a blood transfusion in chronic anemia patients.

A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients with Severe (FVIII <1%) Hemophilia A: Protocol number: 291501

1. To assess tolerability and safety of BAX 826 after a single infusion in previously PTPs with severe hemophilia A.2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE.3. To evaluate the impact of anti- PSA antibodies…

Improving quality of survivorship for breast cancer-related lymphedema by lymphatic microsurgery: A randomized controlled trial

To assess the effectivity of LVA on arm volume in comparison to standard therapy after 12 months.

Implementing Treatment Algorithms for the Cure of Trauma Induced Coagulopathy (iTACTIC)

The primary objective is to compare the haemostatic effect of VHA-guided transfusion strategy versus optimized CCT guided transfusion strategy in haemorrhaging trauma patients. The secondary objectives of the study are to determine the effects of…

Managing Thrombocyte transfusions in a Special Subgroup: NEonates

To assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in reducing the proportion of patients who experience a major bleed or death up to study day 28.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO)

Use of iron chelation therapy has demonstrated benefits in terms of morbidity and mortality for chronically-transfused thalassemia patients with iron overload. Recent retrospective data (Leitch 2007, Rose 2010, Sanz 2008) suggest that overall…

Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease.

To test the hypothesis that IVIG treatment diminish the risk of development of chronic disease, we designed a prospective clinical intervention study in children with newly diagnosed ITP.

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus
Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…