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Hepatitis clinical trials

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NCT ID: NCT05482282 Not yet recruiting - Clinical trials for Hepatitis B Vaccine Adverse Reaction

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

Start date: January 2025
Phase: Phase 3
Study type: Interventional

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

NCT ID: NCT05473403 Not yet recruiting - Risk Factors Clinical Trials

Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis

PRO-SURFASA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical histology, in the absence of other liver disease. Due to the heterogeneity of AIH manifestations, different scoring systems have been validated in order to make a reliable diagnosis. The two most recent scoring systems are: the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG simplified criteria. The second one is recommended by the European Association for the Study of the Liver (EASL) clinical practice guidelines (CPGs). The EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe AIH) is high doses of corticosteroids (superior to 1mg/kg/day) as early as possible and a lack of improvement within seven days should lead to listing for emergency liver transplantation (LT). However, the "lack of improvement" is not objectively defined and the grading of recommendation is III (Opinions of respected authorities). The hypothesis of the study is that the previously developed decisional score on a retrospective series will prospectively allow the differentiation between patients with ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained on treatment and patients who do not respond and should be rapidly evaluated for LT. The score will be computed at day 3 since corticosteroid introduction.

NCT ID: NCT05467553 Not yet recruiting - Hepatitis D Clinical Trials

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Start date: February 24, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection.

NCT ID: NCT05457946 Not yet recruiting - Hepatitis B Clinical Trials

Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

Start date: April 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

NCT ID: NCT05451082 Not yet recruiting - Hepatitis D Clinical Trials

Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

Start date: July 2022
Phase:
Study type: Observational

This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma [hcc], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study. It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF). Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.

NCT ID: NCT05422092 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus With Complication

Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Type 2 diabetes mellitus (T2DM) is always accompanied with nonalcoholic fatty liver disease (NAFLD).This prospective, randomized controlled intervention study was designed to reveal the potential clinical application and underlying mechanisms of canagliflozin in the treatment of type 2 diabetes combined with nonalcoholic fatty liver disease.

NCT ID: NCT05403047 Not yet recruiting - Clinical trials for Hepatitis B Virus - Chronic Active

Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

TOPCHIB
Start date: July 2022
Phase: Phase 4
Study type: Interventional

IIn this study, pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation. The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).

NCT ID: NCT05394623 Not yet recruiting - Hepatitis B Clinical Trials

Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

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

In China, there is no recommendation for Hepatitis D virus (HDV) screening, but the fact is estimated that one-third of the world's population of individuals with chronic Hepatitis B virus (HBV) infection live in China while we do not know the prevalence of co-infection of HBV/HDV in China. So far, no nationwide study has been undertaken to evaluate the epidemiology of hepatitis D, on the other hand, reports of HDV infection rate in different regions of China are not consistent because of the different detection methods and detection objects. Here, we plan to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospital and to know the prevalence and disease burden of HDV in China.

NCT ID: NCT05390424 Not yet recruiting - Hepatitis C Clinical Trials

Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

BUVARD
Start date: June 2022
Phase: N/A
Study type: Interventional

The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users

NCT ID: NCT05372874 Not yet recruiting - Hepatitis C Clinical Trials

Treatment of Hepatitis c by Using Direct-acting Antiviral

Start date: May 6, 2022
Phase:
Study type: Observational

Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).