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NCT ID: NCT03124108 Completed - Clinical trials for Primary Biliary Cholangitis (PBC)

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Start date: April 5, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

NCT ID: NCT03123939 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Phase III B in Acute Lymphoblastic Leukemia

Start date: April 24, 2017
Phase: Phase 3
Study type: Interventional

This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL).

NCT ID: NCT03123900 Completed - Aging Clinical Trials

Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project

Start date: November 26, 2015
Phase: N/A
Study type: Interventional

The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive training - that have been shown to be effective in promoting active and healthy aging. The objective is to study the molecular and neural mechanisms of these strategies to stimulate brain plasticity and improve brain health and cognitive functioning.

NCT ID: NCT03123783 Completed - Cancer Clinical Trials

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Start date: July 10, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.

NCT ID: NCT03123627 Completed - Clinical trials for Kidney Transplant Infection

Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.

Start date: August 23, 2016
Phase: Phase 3
Study type: Interventional

Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin when developing CMV-specific cellular immunity after transplantation. Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 + CMV after transplantation. Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin Patients meeting inclusion criteria will be randomized to: - Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360). - Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90. Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.

NCT ID: NCT03123120 Completed - Colitis, Ulcerative Clinical Trials

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

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

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment. This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.

NCT ID: NCT03122132 Completed - Clinical trials for Hepatitis C Infection

Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

3D8
Start date: February 20, 2017
Phase:
Study type: Observational

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

NCT ID: NCT03120611 Completed - Clinical trials for End Stage Renal Disease

Virtual Reality Versus Conventional Exercise Intradialysis

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.

NCT ID: NCT03119805 Completed - Psoriatic Arthritis Clinical Trials

Remission and Flare in Psoriatic Arthritis: a Prospective 6-month Study With a Double Perspective.

ReFlaP
Start date: May 18, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to define cut-off values of the most widely used composite scores and patient-reported outcomes, for levels corresponding to remission/low disease activity and for changes in levels corresponding to flares, in PsA, when remission/low disease activity and flare are defined from the patient and physician perspective. The ReFlaP (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal, observational study.

NCT ID: NCT03119649 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

Start date: March 18, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.