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Liver Cirrhosis clinical trials

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NCT ID: NCT03995251 Recruiting - Liver Cirrhosis Clinical Trials

Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

Start date: July 4, 2019
Phase: N/A
Study type: Interventional

- Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month. - Study Design- A Prospective Randomized Controlled Trial - Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019 - Sample Size:As shown by Eva Roman et al - in cirhotics with sarcopenia exercise increases mean lean appendicular mass , by 0.38 kg (14 patients, p < 0.03), and Sinclair et al has shown testosterone (22 patients, p <0.05)) to increase mean Appendicular lean mass by +1.69 kg - for 10% increase in APLM - we need to enroll 40 patients in each arm, and considering a los to follow up approx.10% , will require minimum 44 patients in each arm - We will therefore enroll and randomize 100 patients with 50 in each arm. Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations. Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.

NCT ID: NCT03990753 Recruiting - Clinical trials for Compensated Cirrhosis

Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901)

Start date: June 13, 2019
Phase:
Study type: Observational

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy. Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites in China, 1 site in Turkey and 1 site in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

NCT ID: NCT03989973 Recruiting - Liver Cirrhosis Clinical Trials

Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis

Start date: September 1, 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

NCT ID: NCT03981211 Recruiting - Hepatitis C Clinical Trials

Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

TOPIC
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.

NCT ID: NCT03973372 Recruiting - Cirrhosis, Liver Clinical Trials

ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement

Start date: June 10, 2019
Phase:
Study type: Observational [Patient Registry]

ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

NCT ID: NCT03969017 Recruiting - Clinical trials for Cirrhosis of Liver Due to Hepatitis B (Disorder)

Combination Treatment of NAs and Peg IFN α-2b for Hepatitis B Related, Compensatory Cirrhosis Patients

Start date: June 17, 2019
Phase: Phase 2
Study type: Interventional

The study aims to demonstrate that whether treatment of nucleoside (acid)analogues (NAs) plus pegylated interferon (Peg IFN) α-2b for those NAs treated, low level of HBsAg, hepatitis B related compensatory cirrhosis patients will result in higher HBsAg clearance rate and reduce the risk of liver cancer. The investigators plan to enroll about 84 hepatitis B related compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the level of HBsAg <1000IU/ml. These participants will be devided into 2 groups. Group A will receive the treatment of NAs plus Peg IFNα-2b. Group B will be treated with NAs as before enrollment. The participants in both groups will be followed up for 96 weeks. The primary endpoint is to compare the clearance rate of HBsAg between two groups. The secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks follow-up, (2) comparing adverse side effects between the 2 groups. (3) comparing the virological and biochemical responses between the 2 groups.

NCT ID: NCT03957629 Recruiting - Hepatitis B Clinical Trials

Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis

Start date: November 6, 2019
Phase: N/A
Study type: Interventional

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

NCT ID: NCT03945487 Recruiting - Clinical trials for Decompensated Liver Cirrhosis

Mesenchymal Stem Cells Treatment for Decompensated Liver Cirrhosis

Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

Decompensated liver cirrhosis is a life-threatening chronic liver disease with high mortality. Liver transplantation is the only option that can improve the survival of these patients; however, this procedure is associated with several limitations, such as the severe shortage of donor livers, long waiting lists, multiple complications, and high cost. Our and other previous studies have demonstrated that marrow bone-derived mesenchymal stem cells (BM-MSC) or unbilical cord derived MSC (UC-MSC) infusion is clinically safe and could improve liver function in patients with decompensated liver cirrhosis. However, the long-term outcomes of MSC infusion have not been reported until now. This prospective and randomized controlled study examined the longer-term safety and efficacy of UC-MSC in patients with decompensated liver cirrhosis.

NCT ID: NCT03933891 Recruiting - Liver Cirrhosis Clinical Trials

Magnetic Resonance Technics for the Assessment of Liver Function Before and After TIPS

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

Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients. Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. We will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, we will develop new prediction index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt.

NCT ID: NCT03920605 Recruiting - Hepatitis B Clinical Trials

Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis

HBV
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with HBV related liver fibrosis.