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NCT ID: NCT02994927 Completed - Clinical trials for ANCA-Associated Vasculitis

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

ADVOCATE
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

NCT ID: NCT02993406 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

CLEAR Outcomes
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

NCT ID: NCT02990338 Completed - Plasma Cell Myeloma Clinical Trials

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

ICARIA-MM
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the PFS in high risk cytogenetic population in each arm. - To evaluate the Duration of Response (DOR) in each arm. - To evaluate the safety in both treatment arms. - To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. - To evaluate the immunogenicity of isatuximab. - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

NCT ID: NCT02988596 Completed - Concussion, Brain Clinical Trials

Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

Start date: January 2017
Phase: N/A
Study type: Interventional

Approximately 420 professional and amateur athletes will participate in rehabilitation during recovery after sports-related concussion. Participants will be cluster randomized, by study site, to a specific study arm. Participants will complete post-injury assessments and the intervention of their randomized group aimed at understanding the effects of a multidimensional rehabilitation protocol versus enhanced graded exertion on clinical recovery, return to play, and patient outcomes after sport related concussion

NCT ID: NCT02981407 Completed - Clinical trials for Myocardial Infarction

Myocardial Ischemia and Transfusion

MINT
Start date: April 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

NCT ID: NCT02981290 Completed - Healthy Volunteers Clinical Trials

Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants

Start date: July 2008
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants.

NCT ID: NCT02980731 Completed - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).

VENICE II
Start date: December 13, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) with or without the 17p deletion or TP53 mutation, including participants with an unknown status, as well as R/R CLL participants who had been previously treated with B-cell receptor inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may have continued receiving venetoclax for up to 2 years. After the treatment period, participants may have continued on into a 2-year follow-up period.

NCT ID: NCT02967731 Completed - Chronic Sinusitis Clinical Trials

480 Biomedical Sinus Drug Depot

Start date: June 6, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.

NCT ID: NCT02966795 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

ENDURANCE-5 6
Start date: January 25, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

NCT ID: NCT02959138 Completed - Clinical trials for Inflammatory Disease

Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function

Start date: November 21, 2016
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls. Participants in this study will be enrolled using an adaptive design that includes up to 3 enrolled cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in adaptive Cohorts 2 and/or 3.