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Fibrosis clinical trials

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NCT ID: NCT03525548 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

Start date: August 3, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)

NCT ID: NCT03525444 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

NCT ID: NCT03524859 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls.

STS-CF
Start date: May 3, 2018
Phase:
Study type: Observational

Introduction: In recent years, since the discovery of the cystic fibrosis (CF) transmembrane conductance regulator gene in human skeletal muscle, there appears to be growing interest in the measurement of muscle function in CF. One of the most used test in other chronic pulmonary diseases is the Sit-to-Stand test (STS) which consists of simply getting up from a chair. Although the main result of the STS test is the time developed during the task, the velocity and power generated during the task are considered very important variables to detect the functional decline. However, from our knowledge, no study has previously analyzed the differences in time, velocity and muscle power developed during the STS test in patients with CF and their respective healthy controls. Objectives: To compare the values gained from handgrip strength, walking speed and STS test (time, velocity, and muscle power) in a group of patients with CF and their respective healthy controls, and to analyze if these differences (if any) are associated with lung function in patients with CF. Methods: Cross-sectional study with a sample of 60 participants (30 patients diagnosed with CF and 30 healthy subjects) between 18-65 years old. The STS test will be measured through slow-motion video recording with a smartphone device (240 images per second) which will report the time, velocity and power generated during the test. Walking speed and handgrip strength will be also measured. Additionally, the relationship between the variables obtained during the test and the lung function of patients with CF will be analized.

NCT ID: NCT03518697 Completed - Cystic Fibrosis Clinical Trials

Effects of an Individualized Exercise Program on Health-related and Skill/Performance-related ļ¬tness in CF.

Start date: September 10, 2014
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effects of a partially supervised exercise program on different aspects of physical fitness, despite VO2peak, lung function, quality of life and sleep quality in children, adolescents and adults with Cystic Fibrosis.

NCT ID: NCT03517540 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

TANDEM
Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT03516331 Completed - Cystic Fibrosis Clinical Trials

A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

Start date: March 7, 2018
Phase: Phase 1
Study type: Interventional

This is an 2-part study. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL176 with and without co-administration of FDL169 .

NCT ID: NCT03513900 Completed - Cirrhosis Clinical Trials

Non-invasive Methods to Predict PHG in Cirrhosis

Start date: March 6, 2018
Phase:
Study type: Observational

Portal hypertensive gastropathy (PHG) is used to describe the endoscopic appearance of gastric mucosa in patients with cirrhotic portal hypertension, with a characteristic mosaic-like pattern with or without red spots. The severity of PHG can vary from mild to severe, and patients with PHG are at an increased risk of acute and chronic gastrointestinal bleeding. According to the study by Kim et al, severe PHG showed a significantly high-risk of mortality and reduced expected survival time than none or mild PHG. Therefore, we need to detect PHG as soon as possible.However, as an invasive examination, endoscopy examination may massive gastrointestinal bleeding or gastric perforation. Most patients are afraid and disable to tolerate it, which significantly reduces the real morbidity of PHG and delays the time for diagnosis and treatment. Therefore, there is a need to find effective non-invasive methods that can predict patients with PHG in the early stage, especially which require treatment.

NCT ID: NCT03513887 Completed - Cirrhosis Clinical Trials

Noninvasive Tests to Predict the Presence of Esophageal Varices in Patients With Liver Cirrhosis

Start date: February 28, 2018
Phase:
Study type: Observational

Liver cirrhosis is caused by chronic liver diseases, varices exist in 30 - 60% of patients with liver cirrhosis. Variceal bleeding is one of the most important complications of cirrhosis, accelerating the progression of decompensation to a stage at which the patient is at an extremely high risk of death. Endoscopy is the gold standard for the diagnosis of varices, However, periodic endoscopic screening in all cirrhotic patients might unnecessarily induce an invasive and expensive procedure, ultimately increasing not only the medical workload of endoscopy units, but also the financial burden of patients. To avoid unnecessary endoscopy in low- risk patients, some simple, non-invasive and accurate tests have been developed to identify EVs. Such as Transient elastography (TE) , which is a noninvasive tool that measures liver stiffness (LS) correlating to liver fibrosis stage. Moreover, the LS-spleen size-to-platelet ratio score (LSPS), which is a combination of three simple examination methods (LS, spleen size and platelet count) has been established to accurately predict EVs in patients with cirrhosis. Therefore, investigators design this cross-sectional study to assess these non-invasive tests in predicting the presence of EVs in patients with cirrhosis.

NCT ID: NCT03512119 Completed - Clinical trials for Glucose Intolerance or Newly Diagnosis Diabetes

Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor

GLUCORRECTOR
Start date: February 11, 2016
Phase:
Study type: Observational

Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years. At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion. Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group. These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.

NCT ID: NCT03509441 Completed - Diabetes Clinical Trials

Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance

Start date: January 15, 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the relationship between insulin resistance (IR) and myocardial tissue abnormalities. The study will focus on a patient population, South Asians, with a high prevalence of IR.