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Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)

This study has been transitioned to CTIS with ID 2024-510800-35-00 check the CTIS register for the current data. Primary objective:To compare the efficacy of iberdomide, daratumumab and dexamethasone (IberDd) to that of daratumumab, bortezomib and…

Lymphomics; improving the understanding of the anatomy of the lymphatic system and the direction and velocity of lymph flow

To improve the knowledge and understanding of the (patho)physiology of lymph disorders Main objective: the anatomy of the central lymph vessels, the velocity and direction of lymph flow and its influencers and thoracic duct outlet location and…

Long-term integrity of hematopoiesis in pediatric stem cell transplantation survivors

We aim to determine the long-term integrity of hematopoiesis in pediatric and young adult HSCT survivors.

A Phase I/IIb extension study assessing the long-term safety and efficacy of an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) previously administered to adult patients with severe or moderately severe haemophilia B during the CT-AMT-060-01 Phase I/II study.

This study has been transitioned to CTIS with ID 2024-512603-39-00 check the CTIS register for the current data. Primary: To assess the long-term safety (6-10 years after dosing) of a systemic administration of AAV5-hFIX, an AAV vector containing a…

A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)

To evaluate the effect of BIVV020 on the durabilityof platelet response in participants withpersistent/chronic immune thrombocytopenia (ITP)Secondary• To assess the safety and tolerability of BIVV020• To assess the pharmacokinetics (PK) of BIVV020•…

Validation of noninvasive hemoglobin analysis by spectroscopic optical coherence tomography

The objective of this study is to validate the tHb determined by sOCT by comparing it to the tHb from invasive blood sampling. From this comparison, we aim to optimize our data analysis procedure for in vivo sOCT measurements. We also aim to…

SARS-CoV-2 vaccination response in patients with haematological
disease

3.2.1 Primary objectivesTo assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a hematological disorder to SARS-CoV-2 vaccination.3.2.2 Secondary objectives 1. What is the…

The role of B and T cells in ITP

Investigate the relationship between disease activity in ITP and the phenotype and function of autoantigen-specific T cells and B cells.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…

A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody

The aim of this study is to determine whether LNP023 is effective and safe for the treatment of PNH. LNP023 is compared to the Standard of Care (SOC) anti-C5 antibody treatment. The primary objectives are to:• Demonstrate superiority of LNP023…

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study

Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.

A phase I, open-label, randomized, two period, two-way cross over study to assess the influence of a high-calorie, high fat meal on the bioavailability of a 40 mg extended release PHA 022121 oral formulation

In this study we will investigate the influence of a high-calorie, high-fat meal on the uptake, breakdown, and elimination of the study compound PHA-022121. We will also investigate how safe PHA-022121 is and how well it is tolerated when it is used…

Improving the understanding of the anatomy and lymph flow in the central lymphatic system in patients with Noonan Syndrome Spectrum Disorder

To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic…

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

This study has been transitioned to CTIS with ID 2023-505277-32-00 check the CTIS register for the current data. The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

Objective Neurocognitive assessment of young children with sickle cell disease by eye-tracking

The main aim is to study early neurocognitive functioning and development in very young children with SCD. The secondary aims are to identify determinants (risk and protective factors) and biomarkers of early neurocognitive deficits in SCD and to…

An Open-Label Study to Assess the Effects of VMX-C001 in Combination with an Oral FXa DOAC on the Efficacy of Unfractionated Heparin in Healthy Subjects.

This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data. Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase
Deficiency Who Are Regularly Transfused, Followed by a 5-Year Open-label Extension Period

This study has been transitioned to CTIS with ID 2024-515024-37-00 check the CTIS register for the current data. To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the reduction in transfusion burden in…

Predicting platelet age in an intelligent way

Primary Objective:Part 1: to characterize platelets of patients with Lowe syndrome using superresolution microscopy.Part 2: to characterize platelet age in patients receiving chemotherapy for AML using artificial intelligence techniques.Secondary…

The role of Red cell characteristics, Angiogenesis, Viscosity and Oxygenation in the pathophysiology of Sickle cell related retinopathy (RAVOS study)

The aim of this study is to get more insight in the pathogenesis of (P)SCR by comparing: (1) Red cell characteristics (deformability and point of sickling in hypoxia measured by the Oxygenscan), (2) Angiogenesis by determining several biomarkers of…