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NCT ID: NCT03221842 Terminated - Clinical trials for Antibody-mediated Rejection

Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

Start date: November 6, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

NCT ID: NCT03219164 Terminated - Cystic Fibrosis Clinical Trials

Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

ALPINE 2
Start date: November 28, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.

NCT ID: NCT03214627 Terminated - Anemia Clinical Trials

Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial

ANEMEX
Start date: December 10, 2018
Phase: N/A
Study type: Interventional

Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of this ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator. The trial consists of a retrospective (historical) control period and a prospective (going forward) period. During the prospective period, the ACM will be used to assist the Investigators' decision making and will help the Investigators to administer a personalised intravenous (IV) iron and red blood cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.

NCT ID: NCT03211052 Terminated - Prostate Cancer Clinical Trials

A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone

NEPTUNE
Start date: February 18, 2013
Phase: Phase 2
Study type: Interventional

This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an the rate of positive margins at surgery. Translational endpoints include measuring tumoural and plasma testosterone as well as other androgens. Patients with untreated high risk and intermediate risk operable prostate cancer will be treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.

NCT ID: NCT03207815 Terminated - Clinical trials for Noninfectious Uveitis

Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

HUMBOLDT
Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.

NCT ID: NCT03205046 Terminated - DLBCL Clinical Trials

A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Start date: June 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.

NCT ID: NCT03204994 Terminated - Cancer of Rectum Clinical Trials

Fluorescence Targeted Pelvic Lymph Node Mapping

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

This study aims to assess the lymphatic drainage of rectal tumours by using ICG as a fluorescent non-specific marker. As a feasibility study, it will also assess its technique and timing along with its ability to assist in removing lymph nodes when it is clinically indicated.

NCT ID: NCT03204201 Terminated - Surgery Clinical Trials

Validation of ICG to Identify the Urethra During Rectal Surgery

Start date: July 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

NCT ID: NCT03202498 Terminated - Liver Cirrhosis Clinical Trials

Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood. Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis. This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients. Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time. Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is. The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. 56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

NCT ID: NCT03201445 Terminated - Clinical trials for Inflammatory Bowel Disease

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

MANTA
Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD). Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.