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Hepatitis B clinical trials

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NCT ID: NCT04896255 Recruiting - Chronic Hepatitis b Clinical Trials

Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B

OASIS
Start date: May 10, 2021
Phase:
Study type: Observational [Patient Registry]

This is a multicenter, prospective, real-world study, recruiting patients with chronic hepatitis B under anti-viral treatment. The recruited participants will receive peginterferon alpha based regimen or nucleos(t)ide alone. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc)of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. The follow-up time course of this study will be 5 years.

NCT ID: NCT04893616 Completed - Hepatitis B Clinical Trials

Cameroon HepB Birth Dose Feasibility Pilot

Start date: June 10, 2021
Phase: N/A
Study type: Interventional

This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.

NCT ID: NCT04891770 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Start date: August 14, 2021
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).

NCT ID: NCT04886336 Recruiting - HBV Clinical Trials

The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.

HBV
Start date: June 4, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy. In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically. Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.

NCT ID: NCT04886102 Recruiting - Clinical trials for Hepatitis B, Chronic

Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana

Start date: February 11, 2021
Phase:
Study type: Observational

In South America, the prevalence of HBV is variable but high (> 8%) in the Amazon basin. In some areas, a third of HBsAg carriers are also infected with HDV, a major comorbidity factor. The pre-core mutations are associated with the negative HBe Ag phenotype which is associated with a more severe course. These mutations are of increasing and high frequency. French Guiana is populated by populations of African, European and Asian origins with chains of viral transmission which are not known and viruses probably of different origins with variable virulence and transmission potentials.

NCT ID: NCT04870021 Completed - Hepatitis B Clinical Trials

Hepatitis B Birth Dose for Newborns

HepB-BirD
Start date: March 15, 2015
Phase: Phase 4
Study type: Interventional

With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in hyper endemic areas. This hyper endemicity increases the risk of acquiring infection via vertical and horizontal routes of disease transmission. National immunization schedule in Pakistan administers the first vaccine against hepatitis B at 6th week after infant birth. Owing to this 6 week interlude the existing immunization schedule may not provide adequate protection to a newborn against the disease. A monovalent hepatitis B vaccination shot, administered within 12 hours of birth, is the preferred strategy for disease control in hyper endemic areas. The National Immunization Technical Advisory Groups around the world are expected to use rigorous scientific evidence and make changes in the immunization schedule and vaccine dosage, responding to the evolving epidemiology of childhood diseases. Such research on local evidence for hepatitis B vaccine in Pakistan is not available and our research fills this gap by This research studied the hepatitis B vaccine response, in two cohorts of healthy infants. An open labeled, randomized controlled, non-inferiority, vaccine trial methodology was used. Margin of non non-inferiority (Δ) was set at 5%. The trial administered hepatitis B birth dose as an intervention and vaccination done under the national immunization schedule was taken as standard of care.

NCT ID: NCT04868981 Completed - Hepatitis B Clinical Trials

Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets

Start date: May 31, 2021
Phase: Phase 1
Study type: Interventional

To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B (CHB)

NCT ID: NCT04864366 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients

Start date: April 30, 2021
Phase:
Study type: Observational

The objective of this clinical study was to observe the changes of HBsAg levels after a sequential 48 weeks-treatment of TAF in ETV experienced CHB patients and to monitor the levels of cytokines such as IFN-λ3, IP-10, IL-12, IL-10, and IL-21.

NCT ID: NCT04863703 Recruiting - Hepatitis B Clinical Trials

Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

IMPHROVE-D
Start date: May 7, 2021
Phase:
Study type: Observational

Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.

NCT ID: NCT04856085 Recruiting - Clinical trials for Hepatitis B, Chronic

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

MARCH
Start date: July 11, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy