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NCT ID: NCT04170543 Completed - Clinical trials for Diabetic Kidney Disease

A Phase 2b Diabetic Kidney Disease Study

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

NCT ID: NCT04169373 Active, not recruiting - Spondyloarthritis Clinical Trials

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

SELECT-AXIS 2
Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: - To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). - To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). - To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). - To evaluate the maintenance of disease control after withdrawal of upadacitinib.

NCT ID: NCT04167358 Recruiting - Cholestasis Clinical Trials

Linerixibat Long-term Safety, and Tolerability Study

LLSAT
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

NCT ID: NCT04161898 Active, not recruiting - Clinical trials for Takayasu Arteritis (TAK)

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

SELECT-TAK
Start date: February 4, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.

NCT ID: NCT04161495 Completed - Clinical trials for Factor VIII Deficiency

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

XTEND-1
Start date: November 19, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

NCT ID: NCT04158258 Active, not recruiting - Breast Cancer Clinical Trials

A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

Start date: February 21, 2020
Phase:
Study type: Observational

A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.

NCT ID: NCT04157946 Completed - Clinical trials for Respiratory Distress Syndrome, Adult

The Role of Morphological Phenotype in ARDS

MPARDS
Start date: August 7, 2017
Phase:
Study type: Observational

Although most of the information focuses on understanding how the ventilator produces lung damage, the pulmonary factors that predispose to ventilator-induced lung injury (VILI) have been less studied. Acute respiratory distress syndrome (ARDS) can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. This morphological phenotypes may favor the development of VILI for same ventilatory strategy

NCT ID: NCT04157803 Recruiting - Colonic Polyp Clinical Trials

Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

Acetic
Start date: October 25, 2019
Phase: N/A
Study type: Interventional

The use of acetic acid in the characterization of polyps, produces a homogeneous white staining in sessile serrated adenomas, but not in tubular or tubulo-villous adenomas, a simple approach to predict polyp histopathology. To determine the diagnostic accuracy of the use of acetic acid on tubular and serrated adenomas, during colonoscopy, a prospective diagnostic accuracy study was designed, taking as gold standard the pathological anatomy of the resected polyps. Polyps found during a colonoscopy with suspicion of sessile serrated adenomas or tubular/tubulo villous will be included.

NCT ID: NCT04157335 Active, not recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

ORCHID
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel