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NCT ID: NCT03024996 Terminated - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

IMmotion010
Start date: January 3, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

NCT ID: NCT02999633 Terminated - Clinical trials for T-lymphoblastic Lymphoma/Leukaemia

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

ISLAY
Start date: March 8, 2017
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: - To evaluate the safety profile of isatuximab. - To evaluate the duration of response (DOR). - To evaluate progression free survival (PFS) and overall survival (OS). - To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. - To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. - To assess minimal residual disease (MRD) and correlate it with clinical outcome.

NCT ID: NCT02991131 Terminated - Clinical trials for Skin Disease, Infectious

Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

DART
Start date: December 17, 2016
Phase:
Study type: Observational

This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

NCT ID: NCT02975349 Terminated - Clinical trials for Relapsing-remitting Multiple Sclerosis

A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis

Start date: March 7, 2017
Phase: Phase 2
Study type: Interventional

The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.

NCT ID: NCT02975336 Terminated - Clinical trials for Systemic Lupus Erythematosus

A Phase II Study of M2951 in SLE

Start date: January 4, 2017
Phase: Phase 2
Study type: Interventional

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT02956486 Terminated - Alzheimer's Disease Clinical Trials

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

MissionAD1
Start date: October 20, 2016
Phase: Phase 3
Study type: Interventional

The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

NCT ID: NCT02952586 Terminated - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

NCT ID: NCT02940626 Terminated - Clinical trials for Pneumonia, Ventilator-associated

Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

NCT ID: NCT02930161 Terminated - Clinical trials for Non-alcoholic Fatty Liver Disease

Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

Start date: May 30, 2016
Phase: Phase 2
Study type: Interventional

The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with non-alcoholic fatty liver disease and metabolic syndrome.

NCT ID: NCT02927431 Terminated - Virus Diseases Clinical Trials

Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza

Start date: January 19, 2017
Phase: Phase 2
Study type: Interventional

Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza (IFV). While early therapy with antivirals decreases severity and duration of symptoms of influenza, there are no drugs that have demonstrated clinical efficacy in randomized clinical trials in this population. Current treatment guidelines for hospitalized IFV recommend neuraminidase inhibitors as standard of care therapy. IFV studies in animals have demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in clinical scores, lung function and pathology with no evidence of worsening outcomes, including viral load. This Phase 2, randomized, double-blind (for IV DNX), placebo-controlled (for IV DNX) 3-arm study will be the first study to determine the efficacy and safety of IV DNX when co-administered (in all groups) with standard of care antiviral treatment (open-label oral oseltamivir [OSV]) in subjects hospitalized with IFV. The primary objective of the study is to assess the efficacy of treatment with IV DNX twice daily given with oral OSV compared to oral OSV twice daily on time to clinical response (TTCR). In this study, subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg) free base equivalent (FBE) IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All subjects will also receive open-label 75 mg oral OSV, twice daily (given as standard of care). The study treatment duration will be for up to 5 days. The investigator may elect to continue treatment with OSV after 5 days of study treatment. Follow up will continue until Day 45 for all subjects. The study will begin with enhanced safety monitoring in sentinel cohorts, leading to stepwise enrollment of subjects. Subjects will be enrolled based on increasing levels of renal impairment, and less severe hospitalized subjects will be enrolled prior to enrollment of critically ill subjects, as this is the first study conducted in the hospitalized population with severe IFV. Approximately 300 subjects are targeted to be enrolled in the study.