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The Impact of Telemonitoring on correct drug Use, complications and quality of life among patients with Multiple Myeloma (MM);(ITUMM)

The main objective of the project is to study difference between compliance by pill count after 3 months by newly diagnosed multiple myeloma (NDMM) patients with an innovative e-coach, in order to improve treatment compliance by the intervention…

'A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose intravenous and subcutaneous administration and multiple-dose subcutaneous administration of OMS906 in healthy subjects'

The purpose of this study is to investigate how safe the new compound OMS906 is and how well it is tolerated when it is administered to healthy volunteers. OMS906 has not been administered to humans before. It has been previously tested in the…

What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?

1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…

Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

ThThe primary efficacy objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with cancer who have completed at…

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients

To investigate the effect of a daily sachet of probiotics for 12 weeks vs placebo on vitamin K status in renal transplant recipients.

A Phase II, multicenter, randomized, open label two arm study comparing the effect of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients * 16 years with chronic kidney disease due to sickle cell nephropathy

To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease at 12 months

Virtual Reality to Reduce Pain and Anxiety During Acute Pain Episodes in Patients with Sickle Cell Disease

The primary objective is to investigate the efficacy of VR, complementary to standard care, in reducing intensity of pain in SCD patients hospitalized with VOC compared to the efficacy of another distraction method (tablet use) next to standard care…

A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2)

This study has been transitioned to CTIS with ID 2024-512890-28-00 check the CTIS register for the current data. The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line…

Highly restrictive vs normal red blood cell transfusion strategy in anemic critically ill patients - A feasibility trial

The primary objective is feasibility of a prospective randomized trial, to investigate whether a more restrictive RBC transfusion strategy of 5.0 g/dL (3.1 mmol/L) is non-inferior compared to the current transfusion threshold of 7.0 g/dL (4.3mmol/L…

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…

GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

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…

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

The primary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism.The secondary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on…

Pilot study: A comparison of the extent of haemolysis induced by conventional versus miniaturised extracorporeal circulation during coronary artery bypass grafting surgery, and the influence on the release of damage associated molecular patterns (DAMPs), leukocyte activation and neutrophil extracellular trap (NET) formation.

Primary Objective: To compare the extent of haemolysis associated with the use of the conventional versus the miniaturised heart lung machine in the Amphia hospital, with the aim to set up evidence-based guidelines for the use of a specific type of…

A Phase 3, open-label, randomized, multi-center, controlled trial to evaluate the pharmacokinetics and pharmacodynamics of edoxaban and to compare the efficacy and safety of edoxaban with standard of care anticoagulant therapy in pediatric subjects from birth to less than 18 years of age with confirmed venous thromboembolism (VTE)

The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis

Primary objectives: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ISIS 416858 (200, 250, and 300 mg once weekly) as compared to placebo.Exploratory Objectives: Incidence of myocardial infarction (MI), stroke, systemic…

Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold, a randomized controlled trial

Our primary objective is to test our hypothesis that lower Hb thresholds than the current ones, provided adequate cerebral oxygen saturation values are met, will lead to a better neurological outcome in preterm infants at three monts post-term. Our…

More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study

The main objective is to collect data on effect size for, and determine the feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg acenocoumarol on quality of anticoagulation, treatment satisfaction, and medication errors.

A multi-centre, phase II, randomized, double-blind, placebo-controlled study to investigate efficacy and safety of sevuparin infusion for the management of acute vaso-occlusive crisis (VOC) in subjects with sickle-cell disease (SCD)

Primary objective:The primary objective of this study is to assess the time to painful VOC resolution, measured from the first dose of sevuparine given to achievement of crises resolution, as compared to placebo. Secondary objectives: The secondary…