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Hepatitis, Chronic clinical trials

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NCT ID: NCT04643990 Recruiting - Chronic Hepatitis B Clinical Trials

LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF

Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Chronic hepatitis B (CHB) is an important public health problem in the world. There are still more than 250 million chronic hepatitis B virus (CHB) infected people in the world. Its preventive effect has reached a relatively ideal effect, but its therapeutic effect still has great room for improvement. Tenofovir(TDF) is the first-line antiviral treatment with good clinical efficacy. However, some patients who take TDF for a long time have different degrees of renal dysfunction, which limits the use of TDF in these patients. Tenofovir Alafenamide Fumarate (TAF) has better plasma stability and stronger liver targeting, and reduces the side effects of renal function damage and bone mineral density reduction. Telbivudine (LDT), a nucleoside analogue, has the advantages of rapidly reducing HBV viral load and high HBeAg seroconversion rate. In addition, prospective studies have shown that LDT can improve the estimated glomerular filtration rate (EGFR).Therefore, this study aims to explore the clinical study of LDT combined with TDF and TAF in patients treated with tenofovir and EGFR < 90ml / min / 1.72m².

NCT ID: NCT04638439 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection

Start date: December 2021
Phase: Phase 1
Study type: Interventional

Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. To evaluate the rate of ALT normalization

NCT ID: NCT04584242 Recruiting - Clinical trials for Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Start date: September 3, 2020
Phase: Phase 4
Study type: Interventional

The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.

NCT ID: NCT04543565 Recruiting - Chronic Hepatitis b Clinical Trials

Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study

Start date: September 2020
Phase: Phase 3
Study type: Interventional

This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.

NCT ID: NCT04538651 Recruiting - Clinical trials for Hepatitis B, Chronic

A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China

Start date: August 31, 2020
Phase:
Study type: Observational

1. To acknowledge the prevalence of renal insufficiency and kidney-related diseases in patients with chronic hepatitis B in China through epidemiological surveys in outpatient clinics of about 150 hospitals across the country; 2. To analyze the related factors of renal insufficiency and kidney-related diseases in domestic patients with chronic hepatitis B from the aspects of demographic characteristics, family history, antiviral treatment, nephrotoxic drug use history, etc.

NCT ID: NCT04536337 Recruiting - Chronic Hepatitis B Clinical Trials

A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Start date: October 22, 2020
Phase: Phase 1
Study type: Interventional

A Randomized Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

NCT ID: NCT04507607 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

Start date: August 1, 2020
Phase: Early Phase 1
Study type: Interventional

The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

NCT ID: NCT04496882 Recruiting - Chronic Hepatitis b Clinical Trials

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue

CHANGE
Start date: September 9, 2020
Phase: Phase 4
Study type: Interventional

We will conduct a phase 4, multicenter, open-label trial at 7 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 2 years, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF. The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.

NCT ID: NCT04446832 Recruiting - Cirrhosis Clinical Trials

VACcination of LIver Transplantation Candidates

VacLit
Start date: July 6, 2020
Phase:
Study type: Observational

Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit the risk of rejection. Candidates for liver transplantation are at an increased risk for severe infections, some of which can be prevented by vaccination. With regard to vaccine preventable diseases, these patients share the same pitfalls than all immunocompromised individuals: i) a theoretical or proven increased incidence and severity of certain infections warranting specific vaccine recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing vaccine disease after administration of live attenuated vaccines. It is therefore recommended for all patients awaiting liver transplantation: i) updating the vaccinations recommended in general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and chickenpox more common and more serious in this population. However, these recommendations are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination in cirrhotic patients and persistence of post-transplant protection had been poorly assessed as well as their determinants; ii) there are only a few data regarding the tolerance of vaccinations in this population; iii) vaccination coverage of patients with end-stage liver disease is poorly known in France and; iv) the perception and acceptability of vaccinations have not been evaluated in this population. Investigators hypothesis is that: the vaccination schedule currently recommended for liver transplantation does not provide adequate protection against vaccine targets 6 months after liver transplantation.

NCT ID: NCT04318379 Recruiting - Clinical trials for Chronic Hepatitis C Infection

Therapeutic Hepatitis C Virus Vaccine

Start date: April 20, 2021
Phase: Phase 1
Study type: Interventional

GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVaxâ„¢) in chronic HCV patients.