[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656626":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":11,"armGroups":32,"interventions":49,"overallOfficials":60,"centralContacts":64,"locations":11,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom",null,"From Day 1 up to Day 10",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)",{"measure":17,"description":11,"timeFrame":12},"Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms",{"measure":19,"description":11,"timeFrame":20},"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","Up to Day 21",{"allocation":22,"interventionModel":23,"interventionModelDescription":11,"primaryPurpose":24,"observationalModel":11,"timePerspective":11,"maskingInfo":25},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":26,"maskingDescription":27,"whoMasked":28},"TRIPLE","The sponsor and its agents will also be blinded to treatment assignment.",[29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[33,39,45],{"label":34,"type":35,"description":36,"interventionNames":37},"Baloxavir Marboxil","EXPERIMENTAL","HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol.",[38],"Drug: Baloxavir marboxil",{"label":40,"type":41,"description":42,"interventionNames":43},"Placebo","PLACEBO_COMPARATOR","HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol.",[44],"Drug: Placebo",{"label":46,"type":47,"description":48,"interventionNames":11},"No Intervention","NO_INTERVENTION","Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines.",[50,57],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Baloxavir marboxil","Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.",[34],[56],"Xofluza; RO7191686",{"type":51,"name":40,"description":58,"armGroupLabels":59,"otherNames":11},"Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.",[40],[61],{"name":62,"affiliation":5,"role":63},"Clinical Trials","STUDY_DIRECTOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"Roche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":71,"role":67,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656626","phase-3-a-study-to-confirm-efficacy-of-a-single-dose-of-baloxavir-marboxil-in-the-post-exposure-prophylaxis-pep-of-influenza-virus-infection-in-chinese-participants-100656626",false,"NCT07827599","A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants","A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants","Pearlstone","Inclusion Criteria:\n\nIndex Participants (Participants With Influenza Virus Infection):\n\n* First participant in a household with influenza virus infection in the current influenza season\n* Fewer than 6 HHCs\n* Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study\n* Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result\n* Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)\u002FAssent Form\n* PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test\n\nHHCs of Index Participants:\n\n* Lived with the index participant for 48 hours or more prior to informed consent\u002Fassent\n* Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \\\u003C37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge\u002Fnasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza\n* For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents\u002Fcaregivers to evaluate influenza symptoms by using a participant influenza symptoms diary\n* PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test\n\nExclusion Criteria:\n\nHHCs of Index Participants:\n\n* Diagnosed with influenza during the current influenza season\n* Unable to live with the index patient from screening until Day 10\n* Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening\n* Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season\n* Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics\u002Fanalgesics, corticosteroids, or immunosuppressive agents\n* Immunocompromised\n* Use of any medications with anti-influenza effect within 30 days prior to screening\n* Known allergy and\u002For history of significant intolerance against baloxavir marboxil\n* Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply",true,"ALL","5 Years",{"count":86,"type":87},325,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).",[93,94,95],"Influenza, Human","Respiratory Tract Infections","Post-exposure Prophylaxis",[97,34,98],"Influenza","Household Contacts","NOT_YET_RECRUITING","2026-09-15",{"date":102,"type":103},"2026-09-18","ACTUAL",{"date":105,"type":87},"2026-09-22",{"date":107,"type":87},"2027-04-30",{"name":5,"class":6}]