{
  "data" : {
    "id" : "2",
    "type" : "projects",
    "attributes" : {
      "discussion_links" : [ ],
      "extended_attributes" : {
        "extended_metadata_type_id" : "108",
        "attribute_map" : {
          "Resource_classification_Project" : {
            "Resource_classification_type_Project" : "Study"
          },
          "Resource_titles_Project" : [ {
            "Resource_titles_text_Project" : "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",
            "Resource_titles_language_Project" : "German"
          } ],
          "Resource_acronyms_Project" : [ {
            "Resource_acronyms_text_Project" : "STOP-NUC",
            "Resource_acronyms_language_Project" : "English"
          } ],
          "Resource_descriptions_Project" : [ {
            "Resource_descriptions_text_Project" : "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.",
            "Resource_descriptions_language_Project" : "English"
          } ],
          "Resource_keywords_Project" : [ {
            "Resource_keywords_label_Project" : "chronic HBeAg-negative hepatitis B"
          } ],
          "Resource_languages_Project" : [ "English" ],
          "Resource_webpage_Project" : "https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE",
          "Resource_contributors_Project" : [ {
            "Resource_contributors_nameType_Project" : "Personal",
            "Resource_contributors_organisational_Project" : {
              "Resource_contributors_organisational_type_Project" : null,
              "Resource_contributors_organisational_fundingIds_Project" : "",
              "Resource_contributors_organisational_name_Project" : ""
            },
            "Resource_contributors_personal_Project" : {
              "Resource_contributors_personal_type_Project" : "Principal investigator",
              "Resource_contributors_personal_givenName_Project" : "Florian",
              "Resource_contributors_personal_familyName_Project" : "van Bömmel",
              "Resource_contributors_personal_identifiers_Project" : [ {
                "Resource_contributors_personal_identifiers_identifier_Project" : "",
                "Resource_contributors_personal_identifiers_scheme_Project" : null
              } ]
            },
            "Resource_contributors_email_Project" : "Florian.vanBoemmel@medizin.uni-leipzig.de",
            "Resource_contributors_phone_Project" : "+4934197 12200",
            "Resource_contributors_affiliations_Project" : [ {
              "Resource_contributors_affiliations_name_Project" : "Universität Leipzig",
              "Resource_contributors_affiliations_address_Project" : "Liebigstraße 20, 04103 Leipzig",
              "Resource_contributors_affiliations_webpage_Project" : "",
              "Resource_contributors_affiliations_identifiers_Project" : [ {
                "Resource_contributors_affiliations_identifiers_identifier_Project" : "",
                "Resource_contributors_affiliations_identifiers_scheme_Project" : null
              } ]
            } ]
          } ],
          "Resource_idsAlternative_Project" : [ {
            "Resource_idsAlternative_scheme_Project" : "EudraCT",
            "Resource_idsAlternative_identifier_Project" : "2013-004882-15"
          }, {
            "Resource_idsAlternative_scheme_Project" : "DRKS",
            "Resource_idsAlternative_identifier_Project" : "DRKS00006240"
          } ],
          "Resource_nutritionalData_Project" : false,
          "Resource_chronicDiseases_Project" : true,
          "Design_Project" : {
            "Design_primaryDesign_Project" : "Interventional",
            "Design_studyType_Project" : {
              "Design_studyType_interventional_Project" : [ "Unknown" ],
              "Design_studyType_nonInterventional_Project" : [ ]
            },
            "Design_conditions_Project" : [ {
              "Design_conditions_label_Project" : "",
              "Design_conditions_classification_Project" : null,
              "Design_conditions_code_Project" : ""
            } ],
            "Design_groupsOfDiseases_Project" : {
              "Design_groupsOfDiseases_generally_Project" : [ "Certain infectious or parasitic diseases (I)" ],
              "Design_groupsOfDiseases_conditions_Project" : [ ]
            },
            "Design_mortalityData_Project" : null,
            "Design_administrativeInformation_Project" : {
              "Design_administrativeInformation_ethicsCommitteeApproval_Project" : "Request for approval submitted, approval granted",
              "Design_administrativeInformation_status_Project" : "Completed: Recruitment, data collection, and data quality management completed normally",
              "Design_administrativeInformation_statusEnrollingByInvitation_Project" : null,
              "Design_administrativeInformation_startDate_Project" : "",
              "Design_administrativeInformation_endDate_Project" : ""
            },
            "Design_centers_Project" : [ "Multicentric" ],
            "Design_centersNumber_Project" : 24,
            "Design_dataProviders_Project" : null,
            "Design_dataProvidersNumber_Project" : "",
            "Design_subject_Project" : "Person",
            "Design_eligibilityCriteria_Project" : {
              "Design_eligibilityCriteria_ageMin_Project" : {
                "Design_eligibilityCriteria_ageMin_number_Project" : 18,
                "Design_eligibilityCriteria_ageMin_timeUnit_Project" : "Years"
              },
              "Design_eligibilityCriteria_ageMax_Project" : {
                "Design_eligibilityCriteria_ageMax_number_Project" : "",
                "Design_eligibilityCriteria_ageMax_timeUnit_Project" : null
              },
              "Design_eligibilityCriteria_genders_Project" : [ "Male", "Female" ],
              "Design_eligibilityCriteria_inclusionCriteria_Project" : "",
              "Design_eligibilityCriteria_exclusionCriteria_Project" : ""
            },
            "Design_population_Project" : {
              "Design_population_coverage_Project" : "National",
              "Design_population_countries_Project" : [ "Germany" ],
              "Design_population_region_Project" : ""
            },
            "Design_interventions_Project" : [ {
              "Design_interventions_name_Project" : "",
              "Design_interventions_type_Project" : null,
              "Design_interventions_description_Project" : "",
              "Design_interventions_armsLabel_Project" : ""
            } ],
            "Design_exposures_Project" : [ {
              "Design_exposures_name_Project" : "",
              "Design_exposures_type_Project" : null,
              "Design_exposures_description_Project" : "",
              "Design_exposures_groupsLabel_Project" : ""
            } ],
            "Design_outcomes_Project" : [ {
              "Design_outcomes_title_Project" : "",
              "Design_outcomes_description_Project" : "",
              "Design_outcomes_type_Project" : null,
              "Design_outcomes_timeFrame_Project" : ""
            } ],
            "Design_comment_Project" : "",
            "Design_assessments_Project" : [ ],
            "Design_dataSharingPlan_Project" : {
              "Design_dataSharingPlan_generally_Project" : "Yes, there is a plan to make data available",
              "Design_dataSharingPlan_supportingInformation_Project" : [ "Study protocol", "Statistical analysis plan" ],
              "Design_dataSharingPlan_timeFrame_Project" : "",
              "Design_dataSharingPlan_accessCriteria_Project" : "",
              "Design_dataSharingPlan_description_Project" : "",
              "Design_dataSharingPlan_datashield_Project" : "No",
              "Design_dataSharingPlan_requestData_Project" : "",
              "Design_dataSharingPlan_url_Project" : "",
              "Design_dataSharingPlan_recordLinkage_Project" : false
            },
            "Design_nonInterventional_Project" : {
              "Design_nonInterventional_timePerspectives_Project" : [ ],
              "Design_nonInterventional_targetFollowUpDuration_Project" : {
                "Design_nonInterventional_targetFollowUpDuration_number_Project" : "",
                "Design_nonInterventional_targetFollowUpDuration_timeUnit_Project" : null,
                "Design_nonInterventional_targetFollowUpDuration_frequency_Project" : ""
              },
              "Design_nonInterventional_biospecimenRetention_Project" : [ ],
              "Design_nonInterventional_biospecimenDescription_Project" : ""
            },
            "Design_interventional_Project" : {
              "Design_interventional_phase_Project" : "Phase-4",
              "Design_interventional_masking_Project" : {
                "Design_interventional_masking_general_Project" : "",
                "Design_interventional_masking_roles_Project" : [ ],
                "Design_interventional_masking_description_Project" : ""
              },
              "Design_interventional_allocation_Project" : null,
              "Design_interventional_offLabelUse_Project" : null
            }
          },
          "Resource_identifier_Project" : "29151"
        }
      },
      "avatar" : null,
      "title" : "STOP-NUC: 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",
      "description" : "**Coordinating investigator:** Prof. Dr. Florian van Bömmel Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig<br>\r\n**Sponsor:** Universität Leipzig Ritterstr. 26, 04109 Leipzig<br>\r\n**Registration**: EudraCT: 2013-004882-15 DRKS: DRKS00006240\r\n\r\nNucleos(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.",
      "web_page" : "https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004882-15/DE",
      "wiki_page" : null,
      "default_license" : "CC-BY-4.0",
      "start_date" : "2014-11-18",
      "end_date" : "2022-01-30",
      "members" : [ {
        "person_id" : "1",
        "institution_id" : "2"
      }, {
        "person_id" : "3",
        "institution_id" : "2"
      }, {
        "person_id" : "12",
        "institution_id" : "2"
      }, {
        "person_id" : "14",
        "institution_id" : "2"
      }, {
        "person_id" : "7",
        "institution_id" : "3"
      } ],
      "topic_annotations" : [ ]
    },
    "relationships" : {
      "project_administrators" : {
        "data" : [ {
          "id" : "1",
          "type" : "people"
        }, {
          "id" : "3",
          "type" : "people"
        } ]
      },
      "pals" : {
        "data" : [ {
          "id" : "7",
          "type" : "people"
        } ]
      },
      "asset_housekeepers" : {
        "data" : [ ]
      },
      "asset_gatekeepers" : {
        "data" : [ ]
      },
      "organisms" : {
        "data" : [ ]
      },
      "human_diseases" : {
        "data" : [ ]
      },
      "people" : {
        "data" : [ {
          "id" : "1",
          "type" : "people"
        }, {
          "id" : "3",
          "type" : "people"
        }, {
          "id" : "12",
          "type" : "people"
        }, {
          "id" : "14",
          "type" : "people"
        }, {
          "id" : "7",
          "type" : "people"
        } ]
      },
      "institutions" : {
        "data" : [ {
          "id" : "2",
          "type" : "institutions"
        }, {
          "id" : "3",
          "type" : "institutions"
        } ]
      },
      "programmes" : {
        "data" : [ {
          "id" : "1",
          "type" : "programmes"
        } ]
      },
      "investigations" : {
        "data" : [ ]
      },
      "studies" : {
        "data" : [ ]
      },
      "assays" : {
        "data" : [ ]
      },
      "data_files" : {
        "data" : [ ]
      },
      "file_templates" : {
        "data" : [ ]
      },
      "placeholders" : {
        "data" : [ ]
      },
      "models" : {
        "data" : [ ]
      },
      "sops" : {
        "data" : [ ]
      },
      "publications" : {
        "data" : [ {
          "id" : "3",
          "type" : "publications"
        } ]
      },
      "presentations" : {
        "data" : [ ]
      },
      "events" : {
        "data" : [ ]
      },
      "documents" : {
        "data" : [ {
          "id" : "2",
          "type" : "documents"
        }, {
          "id" : "3",
          "type" : "documents"
        } ]
      },
      "workflows" : {
        "data" : [ ]
      },
      "collections" : {
        "data" : [ ]
      }
    },
    "links" : {
      "self" : "/projects/2"
    },
    "meta" : {
      "created" : "2023-03-28T10:34:07.000Z",
      "modified" : "2024-01-31T15:17:48.000Z",
      "api_version" : "0.3",
      "base_url" : "https://ldh.zks.uni-leipzig.de",
      "uuid" : "fe4b0b80-af81-013b-12b4-32b44ecc9602"
    }
  },
  "jsonapi" : {
    "version" : "1.0"
  }
}