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NCT ID: NCT02745119 Terminated - Geographic Atrophy Clinical Trials

Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

Start date: July 21, 2016
Phase: Phase 3
Study type: Interventional

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

NCT ID: NCT02745080 Completed - Psoriatic Arthritis Clinical Trials

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

EXCEED 1
Start date: April 3, 2017
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

NCT ID: NCT02745041 Completed - Trauma Clinical Trials

Fibrinogen Early In Severe Trauma studY

FEISTY
Start date: December 2016
Phase: Phase 2
Study type: Interventional

- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients - Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma - Hypo/dysfibrinogenaemia plays an important role in TIC - Early replacement of fibrinogen may improve outcomes - Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate - The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP - Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP - It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies - Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence - Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay - No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients - Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm - It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) - Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate - It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible

NCT ID: NCT02743806 Terminated - Crohn Disease Clinical Trials

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Start date: August 1, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

NCT ID: NCT02743494 Active, not recruiting - Advanced Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

CheckMate 577
Start date: July 14, 2016
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

NCT ID: NCT02743221 Completed - Clinical trials for Metastatic Colorectal Cancer

A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy

TASCO1
Start date: April 29, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.

NCT ID: NCT02742766 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects

Start date: March 14, 2016
Phase: Phase 1
Study type: Interventional

This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind), three part study. The primary objective of the study is to characterize the safety, and tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28 daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose, dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data and document the decision to proceed as planned or make any alterations in dosing, if indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects, respectively.

NCT ID: NCT02742623 Completed - Clinical trials for Venous Thrombosis and Pulmonary Embolism

A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer

COSIMO
Start date: October 11, 2016
Phase:
Study type: Observational

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

NCT ID: NCT02742519 Terminated - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

Start date: May 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation

NCT ID: NCT02741570 Completed - Clinical trials for Head and Neck Cancer

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

CheckMate 651
Start date: October 5, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer