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Fibrosis clinical trials

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NCT ID: NCT05676112 Withdrawn - Pulmonary Fibrosis Clinical Trials

Safety of Nintedanib in Real World in China

Start date: December 29, 2023
Phase:
Study type: Observational

The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.

NCT ID: NCT05641298 Withdrawn - Cystic Fibrosis Clinical Trials

Study to Determine the Efficacy&Safety of ARV-1801(ACG-701) for the Treatment of Cystic Fibrosis Pulmonary Exacerbations

REPRIEVE
Start date: February 10, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of an oral ARV-1801(ACG-701) plus optimized background therapy (OBT) compared to oral placebo plus OBT, each administered for 14 days, in the treatment of participants with Cystic Fibrosis-related pulmonary exacerbations (PEx).

NCT ID: NCT05583539 Withdrawn - Cirrhosis, Liver Clinical Trials

Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

STRATEGIC
Start date: January 16, 2025
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.

NCT ID: NCT05349760 Withdrawn - IPF Clinical Trials

A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

Start date: March 2023
Phase: Phase 2
Study type: Interventional

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

NCT ID: NCT05229640 Withdrawn - Clinical trials for Cystic Fibrosis-related Diabetes

Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis

Start date: March 31, 2022
Phase: N/A
Study type: Interventional

This study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.

NCT ID: NCT05223881 Withdrawn - Gastroparesis Clinical Trials

Gastroparesis in Cystic Fibrosis

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).

NCT ID: NCT05154656 Withdrawn - Liver Fibrosis Clinical Trials

Three-Dimensional T1rho Using Spiral Fast Spin Echo

Start date: January 1, 2020
Phase:
Study type: Observational

Liver fibrosis is the main feature in early chronic liver diseases. If identified early, liver fibrosis is reversible. The current gold standard for diagnosing liver fibrosis is invasive liver biopsy. Existing non-invasive methods still have significant limitations. T1rho imaging is a promising non-invasive technology evaluating liver fibrosis. It does not require exogenous contrast agent or extra hardware. However, it remains challenging to perform T1rho measurements of the liver. The rich blood signal in the liver introduces quantification errors of liver parenchyma. The existing black blood MRI technologies are based on Cartesian FSE acquisitions, which are not optimal for liver imaging. The residual blood signal is often observed which confounds the measurement. Current T1rho measurement of the liver is mostly performed in two-dimension. 3D coverage of liver is desirable. However, 3D T1rho imaging of liver suffers from long scan time due to increased spatial coverage, reduced scan time efficiency from motion compensation, and high specific absorption rate (SAR). The investigators aim to overcome these challenges by developing 3D T1rho imaging technologies based on magnetization prepared spiral FSE acquisition. Compared to Cartesian FSE, Spiral FSE traverses k-space more efficiently per unit of time, and has reduced SAR due to significantly decreased number of radiofrequency pulses in the echo trains. Spiral acquisition has zero gradient moment at the kspace center, which substantially reduces its sensitivity to respiratory motion. The residual motion manifests as benign incoherent artifacts in the image domain rather than detrimental structured artifacts. Differently to Cartesian FSE, Spiral FSE provides flexibility to design and optimize flow-sensitizing gradients throughout the echo trains to achieve superior suppression of blood signal. The investigators will evaluate the proposed pulse sequences in both healthy controls and patients with liver fibrosis. This project will provide new black blood imaging technologies and a 3D diagnostic tool for early detection of liver fibrosis. This will improve clinical outcomes for patients with chronic liver disease, and provide a springboard for further development of MRI technology for other purposes.

NCT ID: NCT05095246 Withdrawn - Cystic Fibrosis Clinical Trials

A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis

Start date: March 8, 2022
Phase: Phase 1
Study type: Interventional

The Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) to the airways of people with cystic fibrosis via nebulization. This study is designed to evaluate safety and tolerability of KB407 in people with cystic fibrosis. This study will enroll 4 participants into each of the first two cohorts and will enroll five subjects into the last cohort. Cohort 1 will receive a single dose of KB407 and be followed for 60 days. Subjects in Cohort 1 may rollover into Cohort 2 at the Day 28 Visit. A Data Safety Monitoring Board (DSMB) will meet to determine study progress from Cohort 2 into Cohort 3. In Cohort 2, subjects will be dosed bi-weekly at Day 0 and Day 14. In Cohort 3 subjects will be dosed weekly at Day 0, Day 7, Day 14 and Day 21. All subjects will be followed for a year after the last dose of KB407.

NCT ID: NCT05084534 Withdrawn - Clinical trials for Refractory Ascites in Children With Cirrhosis

Efficacy and Safety of Midodrine in Refractory or Recurrent Ascites in Children With Cirrhosis.

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Refractory ascites is seen in 17% of cirrhotic patients with the 1year mortality rate being high, upto 20-50% [1]. The pathogenesis of cirrhotic ascites includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis causing sodium and water retention. The standard medical therapy for the treatment of ascites includes sodium restriction to 2mEq/kg/day with diuretics (Spirinolactone 3-6mg/kg/day and furosemide 0.5-2 mg/kg/day) and therapeutic paracentesis (>50ml/kg/day) with albumin replacement at 8g/L of ascitic fluid tapped. Refractory ascites is defined as ascites that cannot be mobilized by sodium - restricted diet (maximum upto 2mEq/kg/day- 88meq=2gm of salt) and high-dose diuretic treatment (6 mg/kg/day of spironolactone and 2 mg/kg/day of furosemide) or optimum doses of diuretics cannot be given due to development of diuretic-induced complications (Sodium <130mEq, AKI as per KDIGO, hypovolemia, hypo (<3.5meq)/hyperkalemia (>5meq); new onset HE) and recurrent ascites as ascites that has recurred within a 12 weeks period despite standard treatment. All the children and adolescents upto 18 years of age with refractory or recurrent ascites will be included in the study and randomized into 2 groups. One group will receive only standard medical therapy and other group will receive midodrine and standard medical therapy for 12 weeks. Mean arterial pressure will be monitored at every OPD visit. At the end of 12 weeks, plasma renin activity, number of therapeutic paracentesis done, change in serum sodium, estimated glomerular filtration rate and complications will be assessed. If there is complete resolution of ascites, liver transplantation or death before 12 weeks, midodrine will be stopped.

NCT ID: NCT05051293 Withdrawn - Cirrhosis Clinical Trials

Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension

Start date: August 22, 2021
Phase:
Study type: Observational

Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.