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Hepatitis clinical trials

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NCT ID: NCT06463912 Recruiting - Clinical trials for Hepatitis C Virus Infection

Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia

HCV-PIWD
Start date: May 20, 2024
Phase:
Study type: Observational

Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over 20 years. Despite undeniable advances in the treatment of hepatitis C infection and the WHO strategy to eliminate hepatitis C by 2030, this infection continues to be a major public health problem globally and many HCV-positive individuals are unaware of their HIV status. People who inject drugs (PWID) are at increased risk for HCV. Several studies have reported high HCV prevalence rates, especially among PWID. PWID are usually exposed to a higher risk of various infectious diseases, mainly due to their drug consumption behaviors and habits, in addition to the risks and harms associated with the respective routes of self-administration. Worldwide, there are around 11 million PWIDs and there are approximately 2.3 million coinfections between HIV and HCV worldwide, of which more than half (1.3 million) occur in PWID. The coexistence of these two health conditions leads to accelerate the progression of liver disease. The global prevalence of HCV in 2019 among PWID was 50.2%, which is equivalent to 5.6 million people who inject drugs and live with hepatitis C. PWID had been considered a difficult group to reach, manage, and treat because HCV treatment management in these individuals is challenging and they have a higher risk of reinfection and some past HCV treatment guidelines excluded PWIDs from consideration, citing concerns about adherence, increased susceptibility to side effects, and reinfection. However, there is now compelling evidence that HCV treatment is safe and effective among PWID. In Colombia, the prevalence of hepatitis C among PWID has been measured locally in some cities. In Bogotá, it went from 1.7% in 2002 to 6.7% in 2014. For 2021, the prevalence of hepatitis C was measured in Bogotá, Medellín, Santiago de Cali, the metropolitan area of Pereira, Dos Quebradas, Medellín, Cucuta, and Armenia. The results of prevalence of antibodies against hepatitis C were as follows: Cali with 80.2%, is the city with the highest reactivity, followed by Pereira and Dos Quebradas with 71.4%, Armenia with 69.6%, and Cucuta with 62.8%. We do not have recent data about the impact of intervention to reduce HVC transmission in those groups.

NCT ID: NCT06463223 Not yet recruiting - Metabolic Disease Clinical Trials

HIBOC = Hepatic Imaging Biomarkers in Obese Children

Start date: October 2024
Phase:
Study type: Observational

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

NCT ID: NCT06460545 Not yet recruiting - Hepatitis A Clinical Trials

Phase IV Study of Concomitant Administration of the sIPV and HepA

Start date: June 15, 2024
Phase: Phase 4
Study type: Interventional

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

NCT ID: NCT06457477 Recruiting - Chronic Hepatitis B Clinical Trials

Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

NCT ID: NCT06457438 Recruiting - Hepatitis E Clinical Trials

Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

NCT ID: NCT06455280 Not yet recruiting - Cirrhosis, Liver Clinical Trials

SIPLIZUMAB in AILD and LT

SET-SAIL
Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-CD2 monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.

NCT ID: NCT06454760 Not yet recruiting - Clinical trials for Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital

Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital

Start date: September 2024
Phase:
Study type: Observational

1. Determine the predisposing factors of acute hepatitis caused by heptotropic and non-hepatotropic viruses in children attending Assiut Children Hospital . 2. Determine the frequency of acute hepatitis caused by hepatotropic and non-hepatotropic viruses in children attending Assiut Children Hospital

NCT ID: NCT06452693 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

NCT ID: NCT06431945 Recruiting - Clinical trials for Hepatitis C Virus Infection

Early Detection of HCV in Injection Drug Users

EDVIP
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.

NCT ID: NCT06425341 Not yet recruiting - Chronic Hepatitis B Clinical Trials

A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.