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Leukocyte dynamics during immune reconstitution after stem-cell transplantation: in vivo labelling of dividing leukocytes using deuterated water

In this study we aim to gain more insights into immune reconstitution of various leukocyte populations after SCT. By application of heavy water labeling we investigate if and how the production- and death rate of leukocytes changes after an SCT.

A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis

Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.

In vitro investigation into the potential regulating role of sphingolipids in lymphocyte proliferation.

More sustained knowledge of the intracellular processes regarding S1P in lymphocytes could be beneficial in modulating specific immune responses in transplantation medicine, autoimmune diseases and sepsis. Therefore, in this study, we will…

Single center, randomized, double-blind, 3-period, 3 treatments, 3 way crossover pharmacokinetics (PK)/pharmacodynamics (PD) trial to assess PK, PD, safety and tolerability of MYL-1401H after single subcutaneous injection at one dose level (2 mg) comparing to an EU and US marketed drug product (NEULASTA®) in healthy volunteers.

The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…

A Phase 1 Study to Compare the Pharmacokinetics of CAL-101 Capsules to Tablets in Healthy Male Subjects.

Primary: to evaluate the pharmacokinetics of a single 100 mg dose of CAL-101 administered as a capsule (unmicronized formulation), a capsule (micronized formulation) or a tablet in normal healthy male subjectsSecondary: to evaluate the safety of a…

Single-center, double-blind, randomized, placebo-controlled, single-ascending dose
and food interaction study to investigate the tolerability, safety, pharmacokinetics,
and pharmacodynamics of ACT-389949 in healthy male subjects

• to evaluate the safety and tolerability of ascending single oral doses of the test compound ACT-389949 (test medication) in healthy male subjects• to study how the test compound ACT-389949 is absorbed, broken-down and excreted by the body and how…

A PILOT PHASE 1, REPEATED SINGLE DOSE STUDY EVALUATING THE VARIABILITY OF PHARMACOKINETICS AND PHARMACODYNAMICS OF LONG ACTING FILGRASTIM FOLLOWING SUBCUTANEOUS ADMINISTRATION TO HEALTHY VOLUNTEERS

To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.

A phase I double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ascending single doses of ANF-Rho in comparison to standard of care-Neulasta® in healthy volunteers

The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…

Characterization of the immuno-modulatory effects of Tecfidera in multiple sclerosis patients: exploration of drug mechanism and methodological feasibility.

The main purpose of the study is to assess immune cell dynamics in Tecfidera-treated MS patients and untreated healthy subjects, and to explore whether differences in immune cell dynamics exist between both populations. The data generated in this…

Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects.

The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…

COBRA-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after vaccination of a kaleidoscopic group hematological patients, what*s the impact?

1.To investigate COVID-19 vaccine responses of the standard schedule of 2 vaccinations with the Moderna mRNA-1273 vaccine (primary schedule) in patients with hematologic diseases, in particular those patients who are considered immunocompromised,…

Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study).

There have been reports of a more serious course of COVID-19 infections in patients with a reduced immune system, such as patients with congenital immune disorders, (haematological) malignancies or patients taking medications that suppress the…

Multicenter, open*label, phase II study in patients with monoclonal
gammopathy of unknown significance (MGUS) and anti Myelin Associated
Gycoproteine (MAG) Neuropathy and Zanubrutinib Treatment * MAGNAZ trial

Main objective:To improve the functional neurological outcome of patients, as measured on the Raschbuilt Overall Disability Scale (RODS) for inflammatory neuropathies (iRODS) with Zanubrutinib in combination with standard treatment with Rituximab or…

Quantification of leukocyte dynamics in bone marrow of healthy humans

To quantify leukocyte turnover, characterize immune phenotype and function, determine T-cell receptor repertoire, and measure soluble immune factors in bone marrow and blood of healthy adults.

Heavy water labeling of leukocytes in human skin and vet and additional cell populations in fat such as macrophages and adipocytes

The primary objective of this study is to quantify the dynamic properties of different leukocyte subpopulations in healthy skin and blood. Secondly, we aim to understand the relationship between leukocytes in skin and those circulating through the…

A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination with Carfilzomib and Dexamethasone (DKd) Compared with Carfilzomib and Dexamethasone (Kd) in Participants with Multiple Myeloma who have been Previously Treated with Daratumumab to Evaluate Daratumumab Retreatment

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination…

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

This study has been transitioned to CTIS with ID 2023-508897-27-00 check the CTIS register for the current data. Primary:• To compare the efficacy of elranatamab vs lenalidomide Secondary:- To compare the efficacy of elranatamab vs lenalidomide- To…

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

This study has been transitioned to CTIS with ID 2023-510455-28-00 check the CTIS register for the current data. This study is being carried out to investigate the treatment with benralizumab in patients with active HES.The purpose of this study is…

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…

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

This study has been transitioned to CTIS with ID 2024-511407-42-00 check the CTIS register for the current data. Part 1: dose optimizationTo identify a clinically active and tolerable systemic exposure range of bezuclastinib in subjects with…