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	<title>Chronic hepatitis &#8211; European Clinical Trials Information Network</title>
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	<title>Chronic hepatitis &#8211; European Clinical Trials Information Network</title>
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		<title>Study of GS-4321 for Healthy People and Patients With Chronic Hepatitis Delta Virus Infection</title>
		<link>https://clinicaltrials.eu/trial/study-of-gs-4321-for-healthy-people-and-patients-with-chronic-hepatitis-delta-virus-infection/</link>
		
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		<pubDate>Thu, 30 Apr 2026 13:08:45 +0000</pubDate>
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					<description><![CDATA[This study is looking at Chronic Hepatitis Delta, which is a liver infection caused by the hepatitis delta virus. The study will test a treatment called GS-4321, which is a type of monoclonal antibody, meaning it is a laboratory-made protein designed to target specific parts of the virus. Some participants will receive GS-4321 while others [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>This study is looking at <b>Chronic Hepatitis Delta</b>, which is a liver infection caused by the hepatitis delta virus. The study will test a treatment called <b>GS-4321</b>, which is a type of <b>monoclonal antibody</b>, meaning it is a laboratory-made protein designed to target specific parts of the virus. Some participants will receive <b>GS-4321</b> while others will receive <b>placebo</b>. The purpose of the study is to see how safe the treatment is, how well it is tolerated by the body, how the body processes the medication, and whether it can reduce the amount of virus in the blood.</p>
<p>The study has two parts. In Part A, healthy volunteers will receive a single dose of <b>GS-4321</b> given either as an injection under the skin or into a vein. This part will help researchers understand how the medication moves through the body and whether it causes any unwanted effects. In Part B, people who have chronic hepatitis delta infection will receive multiple doses of <b>GS-4321</b> over time. These participants must already be taking certain medications for hepatitis B, such as <b>entecavir</b>, <b>tenofovir alafenamide</b>, or <b>tenofovir disoproxil fumarate</b>. Researchers will check the virus levels in the blood and monitor liver function through blood tests and measurements of liver stiffness using a special imaging method called <b>elastography</b>.</p>
<p>Throughout the study, participants will have regular visits where blood samples will be taken to measure virus levels, check how the liver is working, and look for any side effects. The study will also check whether participants develop immune responses to the medication by looking for <b>antidrug antibodies</b> in the blood. For those in Part B, the treatment period will last up to 96 weeks, with regular monitoring to see how well the medication works in reducing virus levels and improving liver health markers such as <b>alanine aminotransferase</b>, which is a substance in the blood that can indicate liver inflammation.</p>
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