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Fibrosis clinical trials

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NCT ID: NCT06370962 Recruiting - Cystic Fibrosis Clinical Trials

Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators

CHRONO-MUCO
Start date: April 29, 2024
Phase:
Study type: Observational

Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life. Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening. The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbĪ± could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances. In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment. Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset. The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening.

NCT ID: NCT06366425 Not yet recruiting - Fibrosis, Liver Clinical Trials

Screening for Chronic Liver Diseases in General Population

HEPGEN
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

NCT ID: NCT06364462 Not yet recruiting - Liver Fibrosis Clinical Trials

Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

Start date: June 15, 2024
Phase:
Study type: Observational [Patient Registry]

It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.

NCT ID: NCT06364176 Recruiting - Cystic Fibrosis Clinical Trials

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

Start date: June 3, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.

NCT ID: NCT06360094 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

Start date: July 27, 2024
Phase: Phase 2
Study type: Interventional

Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF. During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06358092 Not yet recruiting - Portal Hypertension Clinical Trials

Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.

NCT ID: NCT06356246 Not yet recruiting - Cystic Fibrosis Clinical Trials

Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association.

E-MUCODENT
Start date: August 1, 2024
Phase:
Study type: Observational

Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied. Today, emerging challenges arise due to the increased life expectancy of CF patients, attributed to the rise of modulators such as Kaftrio®, resulting in an adult-majority population in France. The study of periodontal diseases, associated with oral dysbiosis, becomes relevant as they represent bacterial reservoirs that could impact respiratory complications in CF patients. To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results.

NCT ID: NCT06355479 Completed - Hepatic Cirrhosis Clinical Trials

A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia

Start date: April 10, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia. Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients. Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.

NCT ID: NCT06352944 Not yet recruiting - Clinical trials for Non-cystic Fibrosis Bronchiectasis

Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity )

NCT ID: NCT06350474 Completed - Cystic Fibrosis Clinical Trials

Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study

SIMPLIFY-DN
Start date: August 25, 2020
Phase: N/A
Study type: Interventional

Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI). ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use. The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI. This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153. The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCTXXXXXXX (will add once available).