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Hepatitis B clinical trials

View clinical trials related to Hepatitis B.

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NCT ID: NCT04325542 Completed - Hepatitis B Clinical Trials

Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania

HBVPMTCT
Start date: October 1, 2014
Phase: N/A
Study type: Interventional

Chronic Hepatitis B virus (HBV) infection is a neglected disease with devastating consequences, particularly in countries with limited resources for the health sector. Mother-to-child-transmission (MTCT) is responsible for around 50 % of the HBV infections in Tanzania which, in 90 % of the cases, lead to a chronic HBV infection of the child. This infection rate could be reduced with an active immunization directly after birth which is recommended by the World Health Organization (WHO). However, the Tanzanian national immunization programme schedules the first Hepatitis B vaccination for the fourth week after birth which is too late to prevent a perinatal transmission. The aim of the study is to determine the prevalence of Hepatitis B surface antigen (HBsAg) in pregnant women in rural and urban study sites in the region of Mwanza, Tanzania. The blood from the positive -testing mothers should be further examined for viral load, genotype of the virus and for liver transaminases in order to conceive a better understanding of the progression of the infection. Beside the laboratory parameters, risk factors for the infection should be determined with the use of a questionnaire. Furthermore we would like to assess the number of children who were already infected, during the intrauterine period or during birth.

NCT ID: NCT04309526 Completed - Hepatitis B Clinical Trials

Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects

Start date: March 18, 2020
Phase: Phase 1
Study type: Interventional

The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its active metabolite, tenofovir (TFV), in healthy subjects following single oral doses and to evaluate the effect of food on the PK of a 30 mg dose of NCO-48 Fumarate in healthy subjects.

NCT ID: NCT04297917 Completed - Healthy Clinical Trials

First in Human Study of ChAdOx1-HBV

Start date: February 10, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.

NCT ID: NCT04289987 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.

NCT ID: NCT04271592 Completed - Chronic Hepatitis B Clinical Trials

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

Start date: May 17, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.

NCT ID: NCT04264312 Completed - Hepatitis B Clinical Trials

Baseline Investigation of Chronic Hepatitis B Viruses Infections: Who is Eligible for Treated Criteria

Start date: July 28, 2017
Phase:
Study type: Observational

Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population.

NCT ID: NCT04248426 Completed - Clinical trials for Hepatitis B, Chronic

A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection

Start date: February 5, 2020
Phase: Phase 1
Study type: Interventional

This is a double-blinded, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and antiviral activity in both healthy volunteers and volunteers with chronic hepatitis B virus infection. Healthy volunteers will be administered either a single oral dose or multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug. Volunteers with a diagnosis of chronic hepatitis B virus infection will be administered multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

NCT ID: NCT04240678 Completed - Hepatitis B Clinical Trials

The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for chronic hepatitis B.

NCT ID: NCT04209400 Completed - Hepatitis B Clinical Trials

Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

Start date: April 18, 2014
Phase: Phase 3
Study type: Interventional

This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult subjects in Russia.

NCT ID: NCT04199715 Completed - Hepatitis B Clinical Trials

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

Start date: December 3, 2019
Phase: Phase 1
Study type: Interventional

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.