View clinical trials related to Cirrhosis Due to Hepatitis B.
Filter by:This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit components via telehealth or remotely. Visits will include collection of questionnaire data and the in-person visits will include questionnaires, physical exams, imaging, and sample collection.
There are about 240 million chronic hepatitis B virus (HBV) infected people in the world, and about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients every year. Studies have shown that the 5-year survival rate of decompensated cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. Reversing or delaying the process of cirrhosis and reducing the development of compensated cirrhosis to decompensated cirrhosis is one of the effective methods for liver disease treatment. MSCs are mainly derived from bone marrow, but bone marrow mesenchymal stem cells have some shortcomings, such as cumbersome sampling, and the proliferation and differentiation ability of bone marrow mesenchymal stem cells decrease obviously with the age of donors, which is not conducive to cell therapy. Umbilical cord has many advantages, such as wide source, convenient collection, small immune rejection, and small ethical controversy, which makes it a hot spot in stem cell research and has a wider prospect in cell therapy. This clinical study will explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells in the treatment of hepatitis B virus-infected patients with compensated cirrhosis.
Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.