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Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

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 Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…

The effect of Citrus/Cydonia comp.® on hay fever

Several observational studies have shown that Citrus/Cydonia comp. might be an effective treatment option for patients suffering from seasonal allergic rhinitis. In these studies Citrus/Cydonia comp. was either administered subcutaneously or given…

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…

A Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…

A multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential of intravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate to severe COVID-19; The CO-ANNEXIN Study.

Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…

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…

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 MULTICENTER, PHASE 2A, RANDOMIZED,
INVESTIGATOR-BLIND, SUBJECT-BLIND, PARALLEL-GROUP
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF
BIMEKIZUMAB AND CERTOLIZUMAB PEGOL IN SUBJECTS
WITH ACTIVE ANKYLOSING SPONDYLITIS

3.1 Primary objectiveThe primary objective of the study is to evaluate the efficacy of bimekizumab administered scQ2W for 12 weeks compared to CZP in the treatment of subjects with active AS.3.2 Secondary objectivesThe secondary objectives of the…

A MULTIPART EXPLORATORY STUDY TO EVALUATE SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

The Galvani Splenic Neuromodulation System consists of a lead, rechargeable implantable pulse generator, external components and accessories. The system is designed to deliver electrical stimulation to the splenic NVB in patients with moderate to…

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…

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis

To assess the rates of preliminary response and sustained remission of AASV following rituximab (on the basis of former studies, 86% sustained remission expected with rituximab compared to 75% in control group).To assess safety of a rituximab…