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Hepatitis B clinical trials

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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: NCT04180150 Recruiting - Chronic Hepatitis B Clinical Trials

A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.

NCT ID: NCT04166266 Recruiting - Clinical trials for Hepatitis B, Chronic

Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic HBV/HDV Co-infection

BuleDelta
Start date: February 19, 2020
Phase:
Study type: Observational

This is a prospective, multicentric, non comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT.

NCT ID: NCT04157699 Recruiting - Chronic Hepatitis b Clinical Trials

An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b

Start date: July 26, 2019
Phase: Phase 2
Study type: Interventional

This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 100 Subjects who meet all the selection criteria will be randomly assigned 1:1:1:1:1 to (A) QL007 100 mg QD+ Tenofovir dipirofurate fumarate (TDF)300 mg QD, (B) QL007 200 mg QD+ TDF 300 mg QD, (C) QL007 400 mg QD+ TDF 300 mg QD, (D) QL007 200 mg BID+ TDF 300 mg QD, (E) TDF 300 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 in combination with TDF in HBeAg positive patients with chronic hepatitis b, and to recommend a reasonable regimen for phase III study.

NCT ID: NCT04157257 Recruiting - Chronic Hepatitis b Clinical Trials

An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy

Start date: July 26, 2019
Phase: Phase 2
Study type: Interventional

This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 60 Subjects who meet all the selection criteria will be randomly assigned to (A) QL007 200mg BID+ Tenofovir dipirofurate fumarate (TDF)300 mg QD, (B) QL007 200 mg BID+ Entecavir 0.5 mg QD, (C)TDF 300 mg QD, (D) Entecavir 0.5 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 tables in combination with TDF or Entecavir in patients with chronic hepatitis b who have received nucleoside (acid) therapy, and to recommend a reasonable regimen for phase III study.

NCT ID: NCT04139850 Recruiting - Chronic Hepatitis B Clinical Trials

The Establishment of Korean Hepatitis B Patients Cohort

Start date: September 25, 2015
Phase:
Study type: Observational [Patient Registry]

According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea. The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea. The investigators plan to collect more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.

NCT ID: NCT04135235 Recruiting - Clinical trials for Chronic Hepatitis B Infection

Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

Start date: August 1, 2019
Phase:
Study type: Observational

This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.

NCT ID: NCT04133259 Recruiting - Clinical trials for Hepatitis B, Chronic

Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients

Start date: December 31, 2019
Phase: Phase 2
Study type: Interventional

A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.

NCT ID: NCT04112147 Recruiting - Chronic Hepatitis B Clinical Trials

A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

Start date: August 10, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the activity of Antroquinonol in patients with chronic hepatitis B Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with chronic hepatitis B

NCT ID: NCT04102176 Recruiting - Chronic Hepatitis B Clinical Trials

Halting Nucleoside Analogues in Chronic Hepatitis B

HALT-NUCS
Start date: January 29, 2019
Phase: N/A
Study type: Interventional

Most patients with Chronic Hepatitis B are on nucleoside analogy (NA) long term, but this leads to HBsAg loss (defined as functional cure) of only 2% at 6 years. Recently a number of studies have shown significant HBsAg loss rates after stopping nucleoside analogues (NA). However, no criteria to select such patients have been evaluated. Consequently, the objective of the study is not only to determine the proportion of patients able to achieve HBsAg loss in those with qHBsAg≤100IU/ml. The study is designed as a randomised control trial with 1:2 parallel arm randomisation to continuing NA or stopping therapy. Patients will be monitored after stopping therapy for Hepatitis B flares and also to document HBsAg loss.