Treatment Trials

12 Clinical Trials for Various Conditions

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COMPLETED
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.
Description

Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices. Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD). Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.

RECRUITING
A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine
Description

The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.

RECRUITING
A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
Description

The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.

UNKNOWN
Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
Description

The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

COMPLETED
Velacur by Sonic Incytes for Portal Hypertension
Description

This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.

COMPLETED
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Description

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. * Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) * Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

WITHDRAWN
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
Description

The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Although the majority of patients with NAFLD have a benign clinical course, the development of non-alcoholic steatohepatitis (NASH ), with necro-inflammation and progressive fibrosis, increases the risk for development of cirrhosis and its complications. Among patients with NASH, approximately 28% develop cirrhosis over an 8-year follow-up period. NASH and advanced fibrosis is associated with increased morbidity and mortality among those patients with advanced histologic severity such as NASH and fibrosis the gold standard for diagnosing and staging NAFLD is liver biopsy. Liver biopsy is associated with costs and risks that make it impractical for generalized use in a condition that affects such a high portion of the population. Furthermore, liver biopsy is also limited by significant sampling error in NAFLD. Thus, there is a pressing need for accurate non-invasive predictors of NAFLD that would also allow differentiation of those subjects at higher risk of disease progression. At present, in the clinical setting, some demographic factors, blood tests, and imaging studies can be used to predict a higher risk of disease in patients being evaluated for NAFLD. These predictors, however, are of limited sensitivity and specificity compared with liver biopsy. The development and validation of accurate predictors and scoring systems to identify patients at higher risk for NASH and fibrosis would allow identification of subjects who would benefit the most from liver biopsy and potentially help monitor disease

COMPLETED
A Study to Evaluate Liver Stiffness With Shear Wave Elastography
Description

The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis

COMPLETED
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
Description

The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.

RECRUITING
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Description

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

NOT_YET_RECRUITING
HepHospital: A Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Description

This research study is evaluating a program that entails home-based care for people with advanced liver disease.

COMPLETED
Improving Clinician Communication Skills (ICCS)
Description

This research study is a randomized trial to evaluate a training program that is designed to improve the communication skills of clinicians. The training program focuses on care for patients with serious illnesses and their family members, and assesses effectiveness using patient and family outcomes. The long term goal of this research is to improve communication skills of doctors and nurses, thereby improving patient and family outcomes.