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Fibrosis clinical trials

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NCT ID: NCT05537025 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis

Start date: January 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-MMP7 in normal healthy volunteers (NHVs) and in participants with idiopathic pulmonary fibrosis (IPF). The study will initiate with NHVs receiving single ascending doses of ARO-MMP7. Following evaluation of safety and pharmacodynamic (PD) data, participants will receive multiple doses of ARO-MMP7.

NCT ID: NCT05531955 Active, not recruiting - Myocardial Fibrosis Clinical Trials

Pirfenidone Treat Myocardial Fibrosis After Acute Myocardial Infarction

PROTECT-AMI
Start date: August 5, 2022
Phase: Phase 2
Study type: Interventional

Acute myocardial infarction (AMI) is myocardial necrosis caused by acute and continuous ischemia and hypoxia of coronary artery. It can be complicated with arrhythmia, shock or heart failure, which is often life-threatening. The disease is the most common in Europe and the United States, where about 1.5 million people suffer from myocardial infarction every year. China has shown an obvious upward trend in recent years, with at least 500000 new cases every year and at least 2 million current cases . At present, China has a high incidence rate of heart failure after myocardial infarction. The incidence of heart failure within 7 days after myocardial infarction is 19.3%, and the incidence of heart failure from 30 days to 6.7 years after myocardial infarction is 13.1%~37.5%. The incidence of heart failure after myocardial infarction significantly increases the risk of short-term and long-term death, and the prognosis is poor. At present, there is a lack of unified guidance and norms for the diagnosis, treatment and prevention and control strategies of heart failure after myocardial infarction. Cardiac remodeling is the basic pathological process of heart failure after myocardial infarction, and it is also one of the main factors affecting the prognosis of patients. Studies have shown that 30% of AMI have ventricular remodeling 6 months after percutaneous coronary intervention (PCI), and the risk of ventricular remodeling in anterior wall myocardial infarction is the highest. According to foreign literature data, the probability of ventricular remodeling after anterior wall acute myocardial infarction is about 13%, which is 1.9 times higher than that in other parts.Opening the infarct related coronary artery early can save the dying myocardium, reduce the infarct myocardial area and reduce the loss of cardiomyocytes.

NCT ID: NCT05526027 Not yet recruiting - Cystic Fibrosis Clinical Trials

Real-world Efficacy and Safety of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Therapy in Adult Patients With Cystic Fibrosis (CF)

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

In this trial real-world data on the safety (side effects and medication interactions) and efficacy (evolution of lung function testing, chronic bacterial airway infection, quality of life and endo- and exocrine pancreatic function) will be collected in adult people with cystic fibrosis (pwCF) eligible for elexacaftor-tezacaftor-ivacaftor (ETI) up until 2 years after the start of this therapy.

NCT ID: NCT05523180 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the impact of a specific oral probiotic blend on the quality of life of adults with respiratory conditions.

NCT ID: NCT05519020 Recruiting - Cystic Fibrosis Clinical Trials

Inhaled Therapy Adherence and Outcomes to Kaftrio in Cystic Fibrosis

Start date: July 27, 2022
Phase:
Study type: Observational

Cystic fibrosis (CF) is a life-limiting and life-long genetic condition which requires intensive preventative treatment to manage the symptoms and progression of disease. While preventative treatments target the effects of cystic fibrosis, precision medicines target the underlying dysfunction of the cystic fibrosis transmembrane regulator (CFTR) protein at a cell level. The first of these expensive precision medicines also known as modulator therapies, Ivacaftor, was shown to be highly effective in clinical trials with an increase of over 10% in lung function. Real-world studies showed an increase of only 6% and a return to baseline lung function by year five of treatment. Preventative therapies were continued during the Ivacaftor clinical trials whereas there is real world evidence of declining inhaled preventative therapy use following Ivacaftor initiation. This is a potential explanation for the efficacy-effectiveness gap. The first study in the National Efficacy Effectiveness Modulator Optimisation (NEEMO) programme is exploring this (REC ref: 21/HRA/4940, IRAS 301975). Ivacaftor/Tezacaftor/Elexacaftor is the most recent modulator available, commissioned in the UK (United Kingdom) in 2020, and suitable for around 90% of people with cystic fibrosis. It is not yet known if the efficacy effectiveness gap seen with Ivacaftor also exists for Ivacaftor/Tezacaftor/Elexacaftor. There is also uncertainty about the continued need for preventative inhaled therapy alongside the prescription of Ivacaftor/Tezacaftor/Elexacaftor. This second study in the NEEMO programme is a cohort, observational study and will explore adherence to inhaled preventative therapies in adults with cystic fibrosis before and after commencing Ivacaftor/Tezacaftor/Elexacaftor, and in those not prescribed Ivacaftor/Tezacaftor/Elexacaftor. It will also look at the relationship between adherence to preventative inhaled therapy and outcome for adults with CF taking Ivacaftor/Tezacaftor/Elexacaftor. The analysis will use routinely collected pseudo anonymised data from the CFHealthHub learning health system (CFHealthHub), alongside anonymised data from the CF registry and routinely collected clinical data.

NCT ID: NCT05516498 Recruiting - Liver Cirrhosis Clinical Trials

Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

ZEAL
Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

NCT ID: NCT05515627 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Atezolizumab for Idiopathic Pulmonary Fibrosis

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and preliminary efficacy of atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers, in patients with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT05515250 Terminated - Chronic Pain Clinical Trials

Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF. In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk. There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin. With the implementation of this study, investigators hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.

NCT ID: NCT05513950 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF

Start date: January 25, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of CHF10067 (the study drug) and any side effects that might be associated with it. In addition, the study will evaluate how much of the study drug gets into the bloodstream and how long the body takes to remove it. The body's immune response to the study drug will also be evaluated. The study may also evaluate the effect of the study drug on the level of a certain protein in the body. Chiesi is conducting this study on patients affected by idiopathic pulmonary fibrosis (IPF, a lung disease). Chiesi is doing this study to establish the doses suitable for future studies.

NCT ID: NCT05513651 Active, not recruiting - Malnutrition Clinical Trials

Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT

Start date: July 1, 2016
Phase:
Study type: Observational

For all countries, chronic liver disease and liver cirrhosis is one of the important disease burdens. Malnutrition is an important complication of liver cirrhosis, which always runs through the course of liver cirrhosis. According to a lot of scientific research evidence, as the consensus of experts all over the world, malnutrition in patients with liver cirrhosis is closely related to poor outcome. Therefore, early and accurate identification of the risk of malnutrition is very important to improve the prognosis of patients with liver cirrhosis. The purpose of this study was to study the relationship between malnutrition-related indexes and prognosis in patients with liver cirrhosis. 2000 patients with liver cirrhosis were prospectively included, laboratory indexes related to malnutrition and other evaluation indexes were recorded, and long-term follow-up was made to observe the short-term and long-term prognosis of patients with liver cirrhosis. At the same time, a prognostic prediction model was established based on multivariate Cox regression, and a series of in-depth studies and verification were carried out on this basis.