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NCT ID: NCT02579759 Completed - Clinical trials for Charcot-Marie-Tooth Disease Type 1A

Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)

PLEO-CMT
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether PXT3003 is effective and safe in the treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.

NCT ID: NCT02578758 Completed - Depression Clinical Trials

Efficacy of a Transdiagnostic Internet-based Protocol in Community Sample

Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression disorder, dysthymic disorder, obsessive-compulsive disorder and four anxiety disorders: panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive affect/behavioral activation) in a community sample. It will also be tested the differential effect of a specific treatment component based on positive psychology techniques in positive affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be more effective than the WL condition in the primary outcome measures. Investigators also expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.

NCT ID: NCT02577406 Completed - Leukemia, Myeloid Clinical Trials

An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

IDHENTIFY
Start date: December 30, 2015
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

NCT ID: NCT02577042 Completed - Clinical trials for Aging-related Inflammation in HIV-infected Patients

Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen

Start date: October 15, 2015
Phase: Phase 4
Study type: Interventional

Physicians in charge of HIV-infected patients are increasingly being faced to previously unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of renal function, osteopenia/osteoporosis and bone fractures or non-AIDS-defining cancers (1-4). The incidence of these conditions seems to be higher than in the general population but there are controversial data about if these diseases appear at a younger age in HIV-infected patients. The investigators propose a strategy for treatment of elderly HIV-infected patients with a double impact on systemic inflammation and age-related co-morbidities by switching the protease inhibitors by raltegravir, a integrase inhibitor with a neutral effect on lipid and bone metabolism, and adding an statin because of their anti-inflammatory effect. For safety reasons, only patients with maintained viral suppression (documented indetectable viral load for 1 year or more), and no history of virological failure to integrase inhibitors or suspected or documented resistance mutations to the integrase or retrotranscriptase will be candidates for the study. Interleukin -6 and D-dimer are biomarkers that most strongly predict mortality in treated HIV infection and sCD14, sCD163 are soluble markers of monocyte activation that reflect a key source of inflammation and coagulation in HIV infection and predict mortality (26,27). For that reasons, these markers were chosen to determine changes on them after the introduction of the statin and the change of antiretrovirals

NCT ID: NCT02576717 Completed - Multiple Sclerosis Clinical Trials

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

Start date: October 16, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

NCT ID: NCT02576678 Completed - Psoriasis Clinical Trials

A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Start date: October 13, 2015
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a total of 107 weeks which includes screening, treatment (including the PK portion of the study and the extension treatment period), two short-term follow-up periods and a long-term follow-up period.

NCT ID: NCT02576574 Completed - Clinical trials for First Line Non-Small Cell Lung Cancer

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Start date: October 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

NCT ID: NCT02576509 Completed - Clinical trials for Hepatocellular Carcinoma

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT02576197 Completed - Psoriasis Clinical Trials

Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients

Start date: May 2015
Phase: N/A
Study type: Interventional

This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.

NCT ID: NCT02575781 Completed - Neoplasm Malignant Clinical Trials

A Study of SAR428926 in Patients With Advanced Solid Tumors

Start date: October 5, 2015
Phase: Phase 1
Study type: Interventional

Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926 Secondary Objectives: To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites. To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients. To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).