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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…

Influence of BCG vaccine as a booster for TDaP-IPV vaccination

To examine the effect of BCG as an adjuvant on DTP vaccination, and to investigate the non-specific training effects of BCG and DTP, alone and in combination, on the innate immune system.

A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATION THERAPY

The objective of the study is to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.

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…

Effect of mechanical ventilation on plasma cytokine concentrations in healthy humans

Our primary goal is to compare the effects of a positive pressure mechanical ventilation with spontaneous breathing on systemic cytokine release in patients with normal pulmonary function. Secondly, the possible effects of surgery on the ventilation…

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.

The effects of preceding human endotoxemia on the Fluenz-induced immune response, a explorative study

Our primary objective is to investigate the effects of endotoxin-induced systemic inflammation and subsequent development of endotoxin tolerance on the inflammatory response following Fluenz® administration in vivo. To evaluate whether these effects…

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…