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Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…

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 multicenter, double-blind, randomized, active controlled, parallel-group study
to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions
compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis
treated with methotrexate (MTX)

Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…

A Randomized Open Label Study Comparing the Safety, Tolerability and Pharmacokinetics (PK) of Amantadine Hydrochloride and Ribavirin with Oseltamivir Phosphate (TCAD) Administered Orally Versus Oseltamivir alone Administered Orally to Influenza A Virus Infected Hospitalized Immunocompromised Patients

Primary: To determine the safety and tolerability of TCAD administered orally to immunocompromised patients diagnosed with influenza ASecondary: To assess the antiviral effect, the speed of symptom resolution, and the influenza complication rate of…

Mycophenolate sodium (Myfortic) in the Treatment of Uveitis: a Pilot Study.

This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients.

This study has been transitioned to CTIS with ID 2024-512579-11-00 check the CTIS register for the current data. Primary:- To evaluate the short-term safety and tolerability of TX200-TR101 from the day of TX200 TR101 infusion within 28 days post…

Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in a prior clinical study.

This study has been transitioned to CTIS with ID 2024-512580-31-00 check the CTIS register for the current data. PrimaryTo evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.SecondaryTo…

The effects of intra uterine exposure to Tumor Necrosis Factor alpha inhibitors in infants on the development of the immune system

Primary ObjectiveIn order to assess the effects of anti TNFα on the development of adaptive and innate immunity, children exposed to anti TNFα (with or without other immunosuppressive drugs) will be compared to children exposed to immunosuppressive…

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.

Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection.

The primary objectives are to demonstrate the safety and performance of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream…

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

To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…