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Fibrosis clinical trials

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NCT ID: NCT03142191 Terminated - Lung Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

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

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

NCT ID: NCT03069989 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) Imaging

Start date: June 13, 2017
Phase: Phase 1
Study type: Interventional

GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that single nebulized doses of 1−3000 micrograms (mcg) GSK3008348 in healthy volunteers were well tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol. The proposed study is a 2-cohort study of single doses, intended to evaluate the safety, tolerability and PK of the drug in participants with IPF not currently treated with pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort 1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will be designed to further explore safety and to provide additional information on the target engagement profile of GSK3008348. The total duration of the study will be up to 62 days.

NCT ID: NCT03066453 Terminated - Cystic Fibrosis Clinical Trials

Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis

TOBRAMUC
Start date: June 13, 2017
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

NCT ID: NCT03027700 Terminated - Hepatic Steatosis Clinical Trials

Methods to Detect Liver Fibrosis

Start date: January 26, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.

NCT ID: NCT03027635 Terminated - Cirrhosis Clinical Trials

PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

PETRA
Start date: January 20, 2017
Phase: N/A
Study type: Interventional

Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life. This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites. The trial is an investigator initiated, randomised, single blind, parallel arm, controlled trial. Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis. We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival.

NCT ID: NCT03022630 Terminated - Liver Cirrhosis Clinical Trials

Palliative Care for Non-Malignant Diseases (COMPASS Trial)

COMPASS
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.

NCT ID: NCT02989168 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest

Zephyr
Start date: November 2016
Phase: Phase 2
Study type: Interventional

This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.

NCT ID: NCT02971839 Terminated - Cystic Fibrosis Clinical Trials

Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations

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

This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.

NCT ID: NCT02955888 Terminated - Cystic Fibrosis Clinical Trials

Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance

Start date: January 3, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multi-center, double blind, placebo controlled study to evaluate the safety and tolerability of PBI-4050, and its effects on the pancreatic, pulmonary functions and on various biomarkers in Cystic Fibrosis patients with abnormal glucose tolerance. Patients with abnormal glucose tolerance have elevated glucose level either at 1 hour or 2 hour during an Oral Glucose Tolerance Test (OGTT). The Main study will include 24 weeks of treatment with PBI-4050 or matching placebo. At the end of the treatment period, patients will have the option of participating in a 24-week Extension study.

NCT ID: NCT02888730 Terminated - Cystic Fibrosis Clinical Trials

Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients

AVASMUC
Start date: February 16, 2017
Phase: Phase 3
Study type: Interventional

Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial colonization is facilitated by a reduced mucociliary function and some previous studies suggest that the microbiology of the upper airways might influence the microbiology of the lower airway. The aim of this randomized control study is to demonstrate efficacy of antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores, quality of life and lung function