<?xml version="1.0" encoding="UTF-8"?>
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   <map key="resource">
      <array key="ids">
         <map>
            <string key="identifier">https://ldh.zks.uni-leipzig.de/projects/2</string>
            <string key="scheme">URL</string>
            <string key="relationType">A is identical to B</string>
         </map>
      </array>
      <map key="classification">
         <string key="type">Study</string>
      </map>
      <array key="titles">
         <map>
            <string key="text">A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response</string>
            <string key="language">DE (German)</string>
         </map>
      </array>
      <array key="acronyms">
         <map>
            <string key="text">STOP-NUC</string>
            <string key="language">EN (English)</string>
         </map>
      </array>
      <array key="descriptions">
         <map>
            <string key="text">Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg -negative hepatitis B, as functional cure (loss of HBsAg) is rarely achieved. Discontinuation of NUC treatment may lead to functional cure; however, to date, the evidence for this has been based on small or non-randomized clinical trials. The STOP-NUC trial was designed with the aim of increasing the HBsAg loss rate using a NUC treatment interruption approach.\r\n\r\nIn this multicenter, randomized controlled trial, 166 HBeAg-negative chronic hepatitis B patients on continuous long-term NUC treatment, with HBV DNA &lt; 172 IU/mL (1,000 copies/mL) for at least 4 years, were randomized to either stop (Arm A) or continue NUC treatment (Arm B) for a 96-week observation period. In total, 158 patients were available for final analysis, 79 per arm. The primary endpoint was sustained HBsAg loss up to week 96.</string>
            <string key="language">EN (English)</string>
         </map>
      </array>
      <array key="keywords">
         <map>
            <string key="label">chronic HBeAg-negative hepatitis B</string>
         </map>
      </array>
      <array key="languages">
         <string>EN (English)</string>
      </array>
      <string key="webpage">https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE</string>
      <array key="contributors">
         <map>
            <string key="nameType">Personal</string>
            <map key="personal">
               <string key="type">Principal investigator</string>
               <string key="givenName">Florian</string>
               <string key="familyName">van Bömmel</string>
            </map>
            <string key="email">Florian.vanBoemmel@medizin.uni-leipzig.de</string>
            <string key="phone">+4934197 12200</string>
            <array key="affiliations">
               <map>
                  <string key="name">Universität Leipzig</string>
                  <string key="address">Liebigstraße 20, 04103 Leipzig</string>
               </map>
            </array>
         </map>
      </array>
      <array key="idsAlternative">
         <map>
            <string key="scheme">EudraCT</string>
            <string key="identifier">2013-004882-15</string>
         </map>
         <map>
            <string key="scheme">DRKS</string>
            <string key="identifier">DRKS00006240</string>
         </map>
      </array>
      <map key="design">
         <string key="primaryDesign">Interventional</string>
         <map key="studyType">
            <array key="interventional">
               <string>Unknown</string>
            </array>
         </map>
         <map key="groupsOfDiseases">
            <array key="generally">
               <string>Certain infectious or parasitic diseases (I)</string>
            </array>
         </map>
         <map key="administrativeInformation">
            <string key="ethicsCommitteeApproval">Request for approval submitted, approval granted</string>
            <string key="status">Completed: Recruitment, data collection, and data quality management completed normally</string>
         </map>
         <string key="centers">Multicentric</string>
         <number key="centersNumber">24</number>
         <string key="subject">Person</string>
         <map key="eligibilityCriteria">
            <map key="ageMin">
               <number key="number">18</number>
               <string key="timeUnit">Years</string>
            </map>
            <array key="genders">
               <string>Male</string>
               <string>Female</string>
            </array>
         </map>
         <map key="population">
            <string key="coverage">National</string>
            <array key="countries">
               <string>Germany</string>
            </array>
         </map>
         <map key="dataSharingPlan">
            <string key="generally">Yes, there is a plan to make data available</string>
            <array key="supportingInformation">
               <string>Study protocol</string>
               <string>Statistical analysis plan</string>
            </array>
            <string key="datashield">No</string>
         </map>
         <map key="interventional">
            <string key="phase">Phase-4</string>
         </map>
      </map>
      <string key="identifier">29151</string>
   </map>
</map>
