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NCT ID: NCT02554773 Completed - Hemophilia A Clinical Trials

An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

Start date: September 18, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B Secondary Objectives: - To investigate the long-term efficacy of fitusiran - To characterize the safety and efficacy of concomitantly administered Factor VIII (FVIII), Factor IX (FIX) or bypassing agents (BPA) and fitusiran for treatment of bleeding episodes - To assess changes in health-related quality of life (QOL) over time - To characterize antithrombin (AT) reduction and thrombin generation (TG) increase - To characterize the pharmacokinetics (PK) of fitusiran

NCT ID: NCT02552212 Completed - Clinical trials for Axial Spondyloarthritis

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

C-AXSPAND
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.

NCT ID: NCT02549001 Completed - Onychomycosis Clinical Trials

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

Start date: August 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

NCT ID: NCT02547818 Completed - Alzheimer's Disease Clinical Trials

Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease

COGNITE
Start date: September 15, 2015
Phase: Phase 3
Study type: Interventional

This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).

NCT ID: NCT02546700 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 30, 2015
Phase: Phase 2
Study type: Interventional

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

NCT ID: NCT02543112 Recruiting - Asthma Clinical Trials

A Long-term Access Programme for Subjects With Severe Asthma

Start date: August 3, 2015
Phase: Phase 3
Study type: Interventional

This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study 200862 and 200363. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab.

NCT ID: NCT02542293 Active, not recruiting - Clinical trials for Non Small Cell Lung Carcinoma NSCLC

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

NEPTUNE
Start date: November 3, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

NCT ID: NCT02540993 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

FIDELIO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

NCT ID: NCT02537691 Completed - Asthma Clinical Trials

Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Start date: August 28, 2015
Phase: Phase 4
Study type: Interventional

Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.