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Chronic Hepatitis B clinical trials

View clinical trials related to Chronic Hepatitis B.

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NCT ID: NCT05483049 Not yet recruiting - Chronic Hepatitis b Clinical Trials

Prevalence of Significant Liver Fibrosis and Inflammation in Chronic HBV Infected Patients in Grey Zone

Start date: September 1, 2022
Phase:
Study type: Observational

To explore whether normal ALT is associated with liver injury in a cohort of HBV infected patients in grey zone

NCT ID: NCT05466071 Recruiting - Pregnancy Related Clinical Trials

Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load

Start date: July 1, 2021
Phase:
Study type: Observational

Hepatitis B virus (HBV) infection is still a major public health problem worldwide. There are 260 million people with chronic HBV infection in the world, and 890,000 people die of HBV-related diseases annually. Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Fortunately, the morbidity of HBV infection is gradually decreased in China, because newborns are administrated with the combined immunization of hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) widely. However, some infants born of mothers with high HBV DNA load (≥2×10^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Therefore, guidelines including American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of Liver Diseases (EASL) recommend that pregnant women with high HBV DNA load should take anti-hepatitis B viral drugs (tenofovir disoproxil fumarate or terbivudine) to reduce MTCT of HBV from gestation 24-28 weeks. Although tenofovir disoproxil fumarate (TDF) has been classified as B drug for pregnancy by Food and Drug Administration (FDA), some side effects of TDF are reported. For example, neutropenia and the decrease of bone mineral density are found in early age infants who are ever exposed to TDF during their fetal life. Tenofovir alafenamide (TAF), a new prodrug of tenofovir (TFV), has a higher antiviral potency, a higher peripheral blood mononuclear cell (PBMC) intracellular tenofovir diphosphate (TFVpp) level and a lower plasma TFV concentration. As the successor of TDF, the dose of TAF that is took orally every day is approximately 1/10 of TDF. TAF has a much lower risk of kidney toxicity and has almost no effect on the bone mineral density. TAF has been approved and recommended as the first-line drug to treat patients with chronic hepatitis B (CHB) by AASLD, EASL, etc. However, there are relatively few data of TAF on pregnancies with high HBV DNA load. It is urgently to clarify the safety and efficacy of TAF on interrupting MTCT of HBV in pregnancies with high HBV DNA load. In the present study, the investigators enroll middle/late pregnancies with high HBV DNA load(≥2×10^5 IU/ml). The participants are randomly divided into two groups. Then the participants are treated with TAF or TDF respectively. All enrolled participants are followed-up for 2 years. Objectives of the present study are as follows: A. To clarify safety and efficacy of TAF on interrupting MTCT of HBV in middle/late pregnancies with high HBV DNA load. B. To clarify effects of TAF on obstetric complications in middle/late pregnancies with CHB. C. To clarify effects of TAF on birth defects of infants born in mothers with CHB. D. To clarify the change of virology and biochemistry indexes in women with CHB during pregnancy and postpartum. E. To clarify effects of TAF treatment on participants. F. To clarify growth parameters of the infants exposed to TAF during their fetal life. G. To clarify the pharmacokinetics of TAF in pregnant populations.

NCT ID: NCT05457920 Recruiting - Chronic Hepatitis B Clinical Trials

Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.

NCT ID: NCT05451420 Completed - Chronic Hepatitis B Clinical Trials

Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

NCT ID: NCT05435599 Completed - Chronic Hepatitis b Clinical Trials

Serum Regucalcin Level and Chronic Hepatitis B

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

NCT ID: NCT05423834 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Start date: August 1, 2022
Phase:
Study type: Observational [Patient Registry]

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials. The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

NCT ID: NCT05414981 Recruiting - Chronic Hepatitis B Clinical Trials

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

Start date: June 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.

NCT ID: NCT05382351 Recruiting - Clinical trials for Chronic Hepatitis B Virus Infection

Antiviral Therapy for Patients With Chronic Hepatitis B Infection

Start date: May 10, 2022
Phase: Phase 2
Study type: Interventional

The study aims to demonstrate that antiviral therapy for patients with immune tolerance of CHB. On the basis of the original antiviral therapy of entecavir, further clarify the safety and effectiveness of entecavir combined with tenofovir amibufenamide.The investigators plan to enroll about 328 hepatitis B patients,. who are in the stage of immune tolerance. These participants will be devided into two groups randomly .Group A will receive the treatment of entecavir. Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks. The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.

NCT ID: NCT05357235 Recruiting - Chronic Hepatitis B Clinical Trials

The Study on Optimal Treatment and Clinical Outcome of Chronic Hepatitis B Patients With Inactive Hypoviremia

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.

NCT ID: NCT05357183 Recruiting - Chronic Hepatitis B Clinical Trials

The Study on Clinical Outcome and Treatment Optimization of Chronic Hepatitis B Patients With Hypoviremia

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.