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Chronic Hepatitis B clinical trials

View clinical trials related to Chronic Hepatitis B.

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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: 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: NCT04142762 Completed - Chronic Hepatitis B Clinical Trials

A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Start date: October 18, 2019
Phase: Phase 1
Study type: Interventional

This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.

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: 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.

NCT ID: NCT04083716 Completed - Chronic Hepatitis B Clinical Trials

A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults

Start date: September 6, 2019
Phase: Phase 1
Study type: Interventional

This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.

NCT ID: NCT04069858 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B

Start date: December 1, 2016
Phase: Phase 4
Study type: Interventional

Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months

NCT ID: NCT04032275 Completed - Chronic Hepatitis B Clinical Trials

Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection

Start date: January 1, 2018
Phase:
Study type: Observational

This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.