{
  "resource" : {
    "acronyms" : [ {
      "language" : "EN (English)",
      "text" : "STOP-NUC"
    } ],
    "classification" : {
      "type" : "Study"
    },
    "contributors" : [ {
      "affiliations" : [ {
        "address" : "Liebigstraße 20, 04103 Leipzig",
        "name" : "Universität Leipzig"
      } ],
      "email" : "Florian.vanBoemmel@medizin.uni-leipzig.de",
      "nameType" : "Personal",
      "personal" : {
        "familyName" : "van Bömmel",
        "givenName" : "Florian",
        "type" : "Principal investigator"
      },
      "phone" : "+4934197 12200"
    } ],
    "descriptions" : [ {
      "language" : "EN (English)",
      "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 < 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."
    } ],
    "design" : {
      "administrativeInformation" : {
        "ethicsCommitteeApproval" : "Request for approval submitted, approval granted",
        "status" : "Completed: Recruitment, data collection, and data quality management completed normally"
      },
      "centers" : "Multicentric",
      "centersNumber" : 24,
      "dataSharingPlan" : {
        "datashield" : "No",
        "generally" : "Yes, there is a plan to make data available",
        "supportingInformation" : [ "Study protocol", "Statistical analysis plan" ]
      },
      "eligibilityCriteria" : {
        "ageMin" : {
          "number" : 18,
          "timeUnit" : "Years"
        },
        "genders" : [ "Male", "Female" ]
      },
      "groupsOfDiseases" : {
        "generally" : [ "Certain infectious or parasitic diseases (I)" ]
      },
      "interventional" : {
        "phase" : "Phase-4"
      },
      "population" : {
        "countries" : [ "Germany" ],
        "coverage" : "National"
      },
      "primaryDesign" : "Interventional",
      "studyType" : {
        "interventional" : [ "Unknown" ]
      },
      "subject" : "Person"
    },
    "identifier" : "29151",
    "ids" : [ {
      "identifier" : "https://ldh.zks.uni-leipzig.de/projects/2",
      "relationType" : "A is identical to B",
      "scheme" : "URL"
    } ],
    "idsAlternative" : [ {
      "identifier" : "2013-004882-15",
      "scheme" : "EudraCT"
    }, {
      "identifier" : "DRKS00006240",
      "scheme" : "DRKS"
    } ],
    "keywords" : [ {
      "label" : "chronic HBeAg-negative hepatitis B"
    } ],
    "languages" : [ "EN (English)" ],
    "titles" : [ {
      "language" : "DE (German)",
      "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"
    } ],
    "webpage" : "https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE"
  },
  "validation_error" : [ {
    "errorMessage" : "At least one contributor of type 'Creator/Author' is required"
  }, {
    "errorMessage" : "At least one contributor of type 'Contact' is required"
  } ]
}