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Hepatitis B clinical trials

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NCT ID: NCT04674423 Recruiting - Chronic Hepatitis b Clinical Trials

The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.

Start date: May 14, 2020
Phase: Phase 4
Study type: Interventional

In Taiwan, non-cirrhosis CHB patients with mildly elevated ALT are not candidates for antiviral treatment under Taiwan NIH reimbursement criteria. Disease severity could range from mildly liver injury to cirrhosis in this group of patients. There is a substantial population of patients required antiviral treatment, but not fulfill the criteria of reimbursement treatment. For the 2 phase 3 trials of TAF, the treatment criteria of ALT were more than 2x of ULN and did not included liver biopsy as a pre-treatment assessment. In this study, CHB patient with ALT level of 1-2x ULN and significant liver injury evaluated by liver biopsy is the target study population.

NCT ID: NCT04672915 Recruiting - Chronic Hepatitis b Clinical Trials

Prevalence of Occult Hepatitis B Virus Infection(OBI) in Subjects With Chronic Hepatitis B(CHB) Family History

Start date: December 21, 2020
Phase:
Study type: Observational

Mother to Child transmission is the main route of hepatitis B virus (HBV) transmission in China, attributing to over 50% HBV infection. Familial aggregation in HBV infection is well recognized with underlying stipulations like mother-to-child transmission(MTCT), susceptible genes, close contact and other factors. Not surprisingly, a large proportion of hepatitis B virus infected population in China have a family history of hepatitis B virus infection. In clinical practice those family members usually undergo merely hepatitis B virus serology tests without HBV DNA test, which ruled out false HBsAg (-) or Occult HBV Infection (OBI) from Screening and linkage to care (SLTC). Unfortunately, the missed-out OBI in CHB family members was of a greater prevalence compared to those from general population (8.0% vs. 2.6%) . Moreover, OBI has been well recognized as strong risk factor in hepatocellular carcinoma (HCC) development with significant HBV DNA integration into host genome . In light of the latest 2019 China CHB guidelines, treatment criteria covered subjects with family history of CHB related cirrhosis or hepatocellular carcinoma(HCC). Therefore, subjects of HBsAg (+) with normal alanine aminotransferase(ALT) or OBI are eligible for further consideration of HBV anti-viral treatment. This study proposed will explore the prevalence of OBI in subjects with family history of HBV related cirrhosis or HCC. The screened HBsAg (+) with normal alanine aminotransferase(ALT) and OBI subjects would be linked to anti-viral therapies.

NCT ID: NCT04650828 Recruiting - Chronic Hepatitis B Clinical Trials

TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months

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

Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment. Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.

NCT ID: NCT04646928 Recruiting - Chronic Hepatitis B Clinical Trials

Study of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients

Start date: March 17, 2017
Phase:
Study type: Observational

To analyze the incidence of liver cancer after entecavir administration among patients with low viral load and cirrhosis due to chronic hepatitis B infection.

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: NCT04625166 Recruiting - Hepatitis B Clinical Trials

Combi-elastography Assessment of Chronic Liver Disease Multi-center Study

Start date: December 1, 2020
Phase:
Study type: Observational

HITACH developed a new combi-elastography imaging technology combines shear wave imaging and strain imaging technology. In the study, not only the F index which is related to the stage of liver fibrosis can be obtained, but also the A index which is related to the stage of hepatitis can be obtained, which can not be obtained by other ultrasound devices.

NCT ID: NCT04620226 Recruiting - Hepatitis C Clinical Trials

UHN Inpatient Hepatitis C & B Screening

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.

NCT ID: NCT04619082 Recruiting - Clinical trials for Hepatitis B Reactivation

TAF to Prevent HBV Reactivation in Cancer Patients

Start date: July 1, 2021
Phase: Phase 4
Study type: Interventional

Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.

NCT ID: NCT04597164 Recruiting - Clinical trials for Hepatitis B, Chronic

Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

Start date: December 22, 2020
Phase:
Study type: Observational

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.