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Hepatitis clinical trials

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NCT ID: NCT04199819 Recruiting - Clinical trials for Liver Transplant; Complications

Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)

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

After LT, long-term immunosuppressive therapy is required to prevent organ rejection. Therefore, for organs which may harbour OBI, there is a risk of reactivation which may result in liver graft failure. As a consequence, all patients who receive an anti-HBc positive graft will receive antiviral prophylaxis. Currently, all such patients will be commenced on life-long entecavir, which is highly effective in preventing reactivation.2 One major disadvantage of using such a blanket approach is that a significant proportion of anti-HBc donors may not actually have underlying occult HBV infection, and recipients of such grafts may not require lifelong antiviral therapy. Current markers such as HBsAg and HBV DNA are not sensitive enough to detect the presence of OBI. This is the first trial proposed to look at the efficacy of these novel HBV biomarkers in identifying occult HBV infection when used in combination, and to identify patients who will not need long term antiviral prophylaxis.

NCT ID: NCT04199715 Completed - Hepatitis B Clinical Trials

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

Start date: December 3, 2019
Phase: Phase 1
Study type: Interventional

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.

NCT ID: NCT04198584 Completed - Chronic Hepatitis C Clinical Trials

Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients

VC-CBCS
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers.

NCT ID: NCT04196998 Recruiting - Hepatitis B Clinical Trials

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

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

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

NCT ID: NCT04195282 Not yet recruiting - Hepatitis B Clinical Trials

RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF

Start date: December 2019
Phase: N/A
Study type: Interventional

This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.

NCT ID: NCT04195074 Recruiting - Chronic Hepatitis b Clinical Trials

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

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

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

NCT ID: NCT04191018 Recruiting - Hepatitis C Clinical Trials

GastrOesophageal Varices After Sustained Virological Response

GOVaSViR
Start date: November 26, 2019
Phase:
Study type: Observational

Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients. Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE

NCT ID: NCT04190498 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Sleep Apnoea Syndrome and Hepatocellular Carcinoma

ECHAPS
Start date: January 21, 2020
Phase:
Study type: Observational

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

NCT ID: NCT04189627 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

DETI-2
Start date: February 17, 2020
Phase:
Study type: Observational

The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

NCT ID: NCT04189276 Active, not recruiting - Clinical trials for Hepatitis B Virus (HBV)

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

Start date: December 10, 2019
Phase: Phase 2
Study type: Interventional

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.