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Hepatitis clinical trials

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NCT ID: NCT05690607 Not yet recruiting - HIV Infections Clinical Trials

Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B (TINIES for BBVs)

TINIES
Start date: January 23, 2023
Phase:
Study type: Observational

During the Covid-19 pandemic era, patients indicated that they find a model of care incorporating remote consultations to be acceptable [1-3]. Remote accessibility to care can be enhanced by using new technology to allow small volume testing for routine blood samples. This study aims to prospectively validate the use of small volume blood sampling for routine HIV-1 and Hepatitis B Virus (HBV) viral load (VL), liver function tests (LFTs) and creatinine, and assess the acceptability of this method of blood sampling to people living with HIV (PLWH). These tests form the usual minimum required for safe monitoring on a routine basis to determine viral activity, liver and renal function in patients either on or off antiviral therapy. The UK based Doctors Laboratory TINIES small volume blood testing kits comprise microcontainers manufactured by BD Diagnostics designed for sample collection from skin puncture, along with home testing pack with lancets, instructions and Royal Mail postal packs. We will collect TINIES samples alongside routine venepuncture samples in people attending their routine clinic follow ups. We will then send kits to different participants to collect samples in their own home, along with a follow up questionnaire (written/online). Finally, we will conduct a more in-depth telephone interview for a subset of patients to qualitatively assess acceptability. Routine use of this method of testing could revolutionise care of people living with chronic blood borne viruses, for example HIV and chronic HBV. TINIES could enable remote monitoring, increasing ease of access to care, reducing clinic appointment burden in otherwise healthy individuals, and reduce labour costs in the NHS, for example, by reducing phlebotomy appointments.

NCT ID: NCT05649202 Not yet recruiting - Clinical trials for Chronic HIV Infection

Hepatitis C in Prison: Study of Screening and Rapid Treatment (HEPAPRIS)

HEPAPRIS
Start date: January 2023
Phase:
Study type: Observational

Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF. The purpose of this study is to assess the treatment starting delay from the date of incarceration of inmates with chronic HCV infection (hepatitis C).

NCT ID: NCT05614466 Not yet recruiting - Clinical trials for Hepatitis B Virus Related Hepatocellular Carcinoma

The SIMPLY-B Study

Start date: April 2023
Phase: N/A
Study type: Interventional

This study will be conducted in three parts: Part A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care settings before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package. Part B: A nested qualitative health services feasibility study using semi -structured interviews and thematic analysis

NCT ID: NCT05613127 Not yet recruiting - Hepatitis A Clinical Trials

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

Start date: December 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

NCT ID: NCT05601518 Not yet recruiting - Clinical trials for Hepatitis C Infection

Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.

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

Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients. The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide. Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets: Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%). Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.

NCT ID: NCT05523921 Not yet recruiting - HBV Transmission Clinical Trials

Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination

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

The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B will be evaluated to assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV

NCT ID: NCT05503979 Not yet recruiting - Clinical trials for Hepatitis C in Substance Users

Elimination of Hepatitis C Virus Among Users of Substances

EHCUS
Start date: November 15, 2022
Phase:
Study type: Observational

Substance users are a vulnerable group that should be prioritized in HCV (Hepatitis C Virus) elimination efforts in Mexico and in which it is feasible to carry out micro-elimination programs. It is an important group to treat both because of its high prevalence and because of the dynamic spread of infection among the general population. HCV seropositivity has not been documented in this group of people in Mexico City, the metropolitan area and the northern states of the country, nor has the sustained viral response been evaluated in this group of patients in the Mexican population.

NCT ID: NCT05490836 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients

Start date: September 2022
Phase: N/A
Study type: Interventional

The study is aimed to explore the safety and efficacy of the pulse usage , comparing to continuous usage, of Peginterferon alfa-2b Injection (PEG IFN α-2b) Combined With tenofovir alafenamide (TAF) in treatment of naive chronic hepatitis B patients with HBeAg negative.

NCT ID: NCT05483894 Not yet recruiting - Hepatitis B Clinical Trials

Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial

STAPH
Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension

NCT ID: NCT05482295 Not yet recruiting - Vaccine Reaction Clinical Trials

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

Start date: June 2024
Phase: Phase 3
Study type: Interventional

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.