[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658315":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":46,"studyPopulation":33,"armGroups":47,"interventions":61,"overallOfficials":70,"centralContacts":75,"locations":81,"responsibleParty":429,"collaborators":431,"id":434,"slug":435,"hasResults":436,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":33,"eligibilityCriteria":440,"healthyVolunteers":436,"sex":441,"minAge":442,"maxAge":33,"enrollmentInfo":443,"targetDuration":33,"studyType":446,"phases":447,"briefSummary":449,"conditions":450,"keywords":454,"overallStatus":460,"whyStopped":33,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":470},{"fullName":5,"class":6},"Ribocure Pharmaceuticals AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary objective","To evaluate the effect of two dose levels of vortosiran on coagulation Factor XI (FXI) activity.","At Week 8",{"measure":14,"description":15,"timeFrame":16},"Primary endpoint","Percentage change from baseline in FXI activity, compared with placebo.","Baseline to Week 8.",[18,22,25,28,31],{"measure":19,"description":20,"timeFrame":21},"Secondary objective","To evaluate the safety of vortosiran at two dose levels.","Up to week 56",{"measure":19,"description":23,"timeFrame":24},"To assess the plasma exposure of vortosiran after dosing","0 [pre-dose] to 24 hours after dosing.",{"measure":19,"description":26,"timeFrame":27},"To evaluate the effect of 2 dose levels of vortosiran on FXI antigen concentration.","At week 16",{"measure":29,"description":30,"timeFrame":27},"Secondary Objective","To evaluate the effect of 2 dose levels of vortosiran on specific blood coagulation test aPTT.",{"measure":19,"description":32,"timeFrame":27},"To evaluate the effect of 2 doses of vortosiran on specific blood clotting test PT-INR.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial will be conducted in two cohorts. Cohort A and Cohort B are independently enrolled and randomized. Participants are randomized (2:2:1) to low-dose vortosiran, high-dose vortosiran, or matched placebo, with dosing on Day X and Day Y and follow-up through Week 56. This trial aims to evaluate vortosiran in two complementary populations where FXI suppression could provide clinically relevant benefit and where the risk-benefit of conventional anticoagulation is often challenging.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":41},"QUADRUPLE",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Venous thromboembolism, encompassing DVT and PE, is a common condition with a durable risk of recurrence after completion of initial therapy with systemic anticoagulation. In a systematic review and meta-analysis of patients with a first unprovoked VTE who completed at least 3 months of anticoagulant therapy and then discontinued treatment, the cumulative incidence of recurrent VTE was approximately 10% in the first year, 25% at 5 years, and 36% at 10 years, with recurrent events carrying measurable case fatality (Khan et al, 2019). Decisions about extended therapy are frequently individualized because continued anticoagulation reduces VTE recurrence but also exposes patients to ongoing bleeding risk, treatment burden, and complexity of care.\n\nVenous thromboembolism, including in patients with cancer and chemotherapy, remains a major cause of morbidity and mortality. Despite effective anticoagulants, long-term management is constrained by clinically meaningful bleeding risk, drug-drug interactions with anticoagulation therapy, and the need for continuous dosing and adherence. Furthermore, many patients discontinue therapy when they perceive recurrence risk to be moderate or when bleeding risk, treatment burden, or patient preference argues against indefinite anticoagulation. These combined factors constitute an unmet need for a convenient strategy that can reduce recurrent VTE risk with a lower risk of bleeding.\n\nVortosiran is a subcutaneously administered siRNA designed to selectively inhibit hepatic synthesis of FXI, resulting in robust and durable suppression of FXI activity. FXI inhibition is novel and innovative anti-thrombotic strategy inhibiting blood clot formation by the intrinsic pathway without interfering with hemostatic control through the extrinsic and commen clotting pathways. Thereby reducing blood clot formation and VTE without increasing the risk of bleeding compared to current available anti-coagulant treatments.\n\nThis Phase II trial is designed to establish dose-related FXI suppression, characterize safety with repeated dosing, and generate an initial signal on clinical outcomes in two VTE prevention settings.\n\nThis multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial will be conducted in two cohorts. Cohort A and Cohort B are independently enrolled and randomized. Participants are randomized (2:2:1) to low-dose vortosiran, high-dose vortosiran, or matched placebo, with dosing on Day X and Day Y and follow-up through Week 56. This trial aims to evaluate vortosiran in two complementary populations where FXI suppression could provide clinically relevant benefit and where the risk-benefit of conventional anticoagulation is often challenging.\n\n* Cohort A (post-VTE, with participants judged to be at equipoise for extended therapy): Participants have completed 3 to 12 months of standard anticoagulation for symptomatic proximal DVT and\u002For PE as originally prescribed, and have had no recurrence during that initial treatment period. The cohort is restricted to patients for whom discontinuation of anticoagulation is consistent with local standard of care and where there is true equipoise about extended therapy vs only follow-up and observation.\n* Cohort B (active cancer; high VTE risk): Ambulatory patients initiating a new course of systemic chemotherapy and with intermediate to high VTE risk (Khorana score ≥2), but no history of prior VTE.",[48,53,56],{"label":49,"type":50,"description":33,"interventionNames":51},"Low-dose group","ACTIVE_COMPARATOR",[52],"Drug: Vortosiran",{"label":54,"type":50,"description":33,"interventionNames":55},"High-dose group",[52],{"label":57,"type":58,"description":33,"interventionNames":59},"Placebo","PLACEBO_COMPARATOR",[60],"Drug: Placebo",[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":33},"DRUG","Vortosiran","Vortosiran, active drug.",[54,49],{"type":63,"name":57,"description":68,"armGroupLabels":69,"otherNames":33},"Placebo that is identical in appearance of active IMP.",[57],[71],{"name":72,"affiliation":73,"role":74},"Anders Gabrielsen, MD, PhD","Ribocure Pharmaceuticals","STUDY_DIRECTOR",[76],{"name":77,"role":78,"phone":79,"phoneExt":33,"email":80},"Rebeckha Magnusson, Head Clinical Operations","CONTACT","+46 31 72 07 800","rebeckha.magnusson@ribocure.com",[82,98,109,121,130,137,146,156,168,182,194,206,218,232,244,256,268,280,292,304,316,328,337,346,360,372,384,396,408,417],{"facility":83,"status":33,"city":84,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Multiprofile Hospital For Active Treatment - Pazardzhik AD","Pazardzhik","Bulgaria","BG",{"type":88,"coordinates":89},"Point",[90,91],24.33318,42.19934,{"lat":91,"lon":90},[94,96],{"name":95,"role":78,"phone":33,"phoneExt":33,"email":33},"Petar Lazov, Doctor",{"name":95,"role":97,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"facility":99,"status":33,"city":100,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Specialized Hospital for Active Treatment in Cardiology - Medica Cor EAD","Rousse",{"type":88,"coordinates":102},[103,104],25.9534,43.84872,{"lat":104,"lon":103},[107],{"name":108,"role":78,"phone":33,"phoneExt":33,"email":33},"Dobrin Vasilev, Professor",{"facility":110,"status":33,"city":111,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Acibadem City Clinic Tokuda University Hospital EAD","Sofia",{"type":88,"coordinates":113},[114,115],23.32415,42.69751,{"lat":115,"lon":114},[118,120],{"name":119,"role":78,"phone":33,"phoneExt":33,"email":33},"Milena Staneva, Professor",{"name":119,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":122,"status":33,"city":111,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Multiprofile Hospital for Active Treatment \"National Cardiology Hospital\" EAD",{"type":88,"coordinates":124},[114,115],{"lat":115,"lon":114},[127,129],{"name":128,"role":78,"phone":33,"phoneExt":33,"email":33},"Elena Goranova Lazarova, Professor",{"name":128,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":122,"status":33,"city":111,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},{"type":88,"coordinates":132},[114,115],{"lat":115,"lon":114},[135],{"name":136,"role":78,"phone":33,"phoneExt":33,"email":33},"Nadelin Nikolov, Associate Professor",{"facility":138,"status":33,"city":111,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"University Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD",{"type":88,"coordinates":140},[114,115],{"lat":115,"lon":114},[143,145],{"name":144,"role":78,"phone":33,"phoneExt":33,"email":33},"Rossen Stoytchev, Associate Professor",{"name":144,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":147,"status":33,"city":111,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"University Multiprofile Hospital for Active Treatment \"Alexandrovska\"",{"type":88,"coordinates":149},[114,115],{"lat":115,"lon":114},[152,154],{"name":153,"role":78,"phone":33,"phoneExt":33,"email":33},"Kirik Karamfiloff, Professor",{"name":155,"role":97,"phone":33,"phoneExt":33,"email":33},"Kiril Karamfiloff, Professor",{"facility":157,"status":33,"city":158,"state":33,"zip":33,"country":85,"countryCode":86,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Multiprofile District Hospital for Active Treatment \"Dr. Stefan Cherkezov\" AD","Veliko Tarnovo",{"type":88,"coordinates":160},[161,162],25.62904,43.08124,{"lat":162,"lon":161},[165,167],{"name":166,"role":78,"phone":33,"phoneExt":33,"email":33},"Shkvarla Lyuboslav, Doctor",{"name":166,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":169,"status":33,"city":170,"state":33,"zip":33,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Centre Oncologie Radiotherapie (CORT 37)","Chambray-lès-Tours","France","FR",{"type":88,"coordinates":174},[175,176],0.70286,47.33537,{"lat":176,"lon":175},[179,181],{"name":180,"role":78,"phone":33,"phoneExt":33,"email":33},"Pierre Combe, Doctor",{"name":180,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":183,"status":33,"city":184,"state":33,"zip":33,"country":171,"countryCode":172,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Louis-Mourier (AP-HP)","Colombes",{"type":88,"coordinates":186},[187,188],2.25404,48.91882,{"lat":188,"lon":187},[191,193],{"name":192,"role":78,"phone":33,"phoneExt":33,"email":33},"Isabelle Mahe, Doctor",{"name":192,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":195,"status":33,"city":196,"state":33,"zip":33,"country":171,"countryCode":172,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"CHU de Grenoble","Grenoble",{"type":88,"coordinates":198},[199,200],5.71479,45.17869,{"lat":200,"lon":199},[203,205],{"name":204,"role":78,"phone":33,"phoneExt":33,"email":33},"Gilles Pernod, Professor",{"name":204,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":207,"status":33,"city":208,"state":33,"zip":33,"country":171,"countryCode":172,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Hôpital Européen Georges Pompidou (HEGP)","Paris",{"type":88,"coordinates":210},[211,212],2.3488,48.85341,{"lat":212,"lon":211},[215,217],{"name":216,"role":78,"phone":33,"phoneExt":33,"email":33},"Olivier Sanchez, Professor",{"name":216,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":219,"status":33,"city":220,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Cardiology Office Individual Specialist Medical Practice Elżbieta Dułak","Gdynia","Poland","PL",{"type":88,"coordinates":224},[225,226],18.53188,54.51889,{"lat":226,"lon":225},[229,231],{"name":230,"role":78,"phone":33,"phoneExt":33,"email":33},"Elzbieta Dulak, Doctor",{"name":230,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":233,"status":33,"city":234,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Oddział Kardiologii SPS Szpital Zachodni im św Jana Pawła iI","Grodzisk Mazowiecki",{"type":88,"coordinates":236},[237,238],20.6337,52.10387,{"lat":238,"lon":237},[241,243],{"name":242,"role":78,"phone":33,"phoneExt":33,"email":33},"Janusz Bednarski, Doctor",{"name":242,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":245,"status":33,"city":246,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Uniwersytet Jagiellonski Collegium Medicum","Krakow",{"type":88,"coordinates":248},[249,250],19.93658,50.06143,{"lat":250,"lon":249},[253,255],{"name":254,"role":78,"phone":33,"phoneExt":33,"email":33},"Grzegorz Kopec, Professor",{"name":254,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":257,"status":33,"city":258,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"\"Department of Cardiology European Health Center Otwock\"","Otwock",{"type":88,"coordinates":260},[261,262],21.26129,52.10577,{"lat":262,"lon":261},[265,267],{"name":266,"role":78,"phone":33,"phoneExt":33,"email":33},"Marcin Kurzyna, Professor",{"name":266,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":269,"status":33,"city":270,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"University Clinical Research Support Center of Medical University in Poznan","Poznan",{"type":88,"coordinates":272},[273,274],16.92993,52.40692,{"lat":274,"lon":273},[277,279],{"name":278,"role":78,"phone":33,"phoneExt":33,"email":33},"Gabriel Marcin, Professor",{"name":278,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":281,"status":33,"city":282,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Clinical Oncology Department, Mazowiecki Szpital Wojewódzki","Siedlce",{"type":88,"coordinates":284},[285,286],22.29006,52.16772,{"lat":286,"lon":285},[289,291],{"name":290,"role":78,"phone":33,"phoneExt":33,"email":33},"Marta Czeluścińska-Murawiec, Doctor",{"name":290,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":293,"status":33,"city":294,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Aidport Sp. z o.o.","Skorzewo",{"type":88,"coordinates":296},[297,298],17.97006,54.16909,{"lat":298,"lon":297},[301,303],{"name":302,"role":78,"phone":33,"phoneExt":33,"email":33},"Michal Kwiatek, Doctor",{"name":302,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":305,"status":33,"city":306,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Zachodniopomorskie Centrum Onkologii","Szczecin",{"type":88,"coordinates":308},[309,310],14.55302,53.42894,{"lat":310,"lon":309},[313,315],{"name":314,"role":78,"phone":33,"phoneExt":33,"email":33},"Katarzyna Hetman, Doctor",{"name":314,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":317,"status":33,"city":318,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Centrum Medyczne LUX MED sp zoo ul 1 Sierpnia 8, 02-143 Warszawa","Warsaw",{"type":88,"coordinates":320},[321,322],21.01178,52.22977,{"lat":322,"lon":321},[325,327],{"name":326,"role":78,"phone":33,"phoneExt":33,"email":33},"Piotr Pruszczyk, Professor",{"name":326,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":329,"status":33,"city":318,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":330,"geoPoint":332,"contacts":333},"Klinika Sienna Sp. z o.o.",{"type":88,"coordinates":331},[321,322],{"lat":322,"lon":321},[334,336],{"name":335,"role":78,"phone":33,"phoneExt":33,"email":33},"Jacek Opalinski, Doctor",{"name":335,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":338,"status":33,"city":318,"state":33,"zip":33,"country":221,"countryCode":222,"cosmosGeoPoint":339,"geoPoint":341,"contacts":342},"Maria Skłodowska-Curie National Research Institute of Oncology",{"type":88,"coordinates":340},[321,322],{"lat":322,"lon":321},[343,345],{"name":344,"role":78,"phone":33,"phoneExt":33,"email":33},"Lucjan Wyrwicz, Professor",{"name":344,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":347,"status":33,"city":348,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Gral Medical - Oncofort Pitesti","Piteşti","Romania","RO",{"type":88,"coordinates":352},[353,354],24.86667,44.85,{"lat":354,"lon":353},[357,359],{"name":358,"role":78,"phone":33,"phoneExt":33,"email":33},"Adela Lucia Chirila, Doctor",{"name":358,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":361,"status":33,"city":362,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Satu Mare County Emergency Hospital","Satu Mare",{"type":88,"coordinates":364},[365,366],22.86255,47.79926,{"lat":366,"lon":365},[369,371],{"name":370,"role":78,"phone":33,"phoneExt":33,"email":33},"Maria Melinda Kurtinecz, Doctor",{"name":370,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":373,"status":33,"city":374,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Spitalul European Polisano - Constitutiei Sibiu","Sibiu",{"type":88,"coordinates":376},[377,378],24.15,45.8,{"lat":378,"lon":377},[381,383],{"name":382,"role":78,"phone":33,"phoneExt":33,"email":33},"Victor Nimirceag, Doctor",{"name":382,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":385,"status":33,"city":386,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Sigmedical Services S.R.L.","Suceava",{"type":88,"coordinates":388},[389,390],26.25,47.63333,{"lat":390,"lon":389},[393,395],{"name":394,"role":78,"phone":33,"phoneExt":33,"email":33},"Doina Elena Ganea, Professor",{"name":394,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":397,"status":33,"city":398,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"Centrul Medical Cardiomed","Târgu Mureş",{"type":88,"coordinates":400},[401,402],24.55747,46.54245,{"lat":402,"lon":401},[405,407],{"name":406,"role":78,"phone":33,"phoneExt":33,"email":33},"Imre Benedek, Professor",{"name":406,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":409,"status":33,"city":398,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":410,"geoPoint":412,"contacts":413},"Spitalul Clinic Judeţean Mureş",{"type":88,"coordinates":411},[401,402],{"lat":402,"lon":401},[414,416],{"name":415,"role":78,"phone":33,"phoneExt":33,"email":33},"Attila Frigy, Associate Professor",{"name":415,"role":97,"phone":33,"phoneExt":33,"email":33},{"facility":418,"status":33,"city":419,"state":33,"zip":33,"country":349,"countryCode":350,"cosmosGeoPoint":420,"geoPoint":424,"contacts":425},"Institutului de Boli Cardiovasculare Timişoara","Timișoara",{"type":88,"coordinates":421},[422,423],21.22571,45.75372,{"lat":423,"lon":422},[426,428],{"name":427,"role":78,"phone":33,"phoneExt":33,"email":33},"Dan Gaita, Professor",{"name":427,"role":97,"phone":33,"phoneExt":33,"email":33},{"type":430,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[432],{"name":433,"class":6},"Fortrea","100658315","phase-2-vortosiran-for-vte-prevention-100658315",false,"NCT07850453","Vortosiran for VTE Prevention","Randomized, Double-blind, Phase II Trial of Vortosiran to Evaluate Safety, Tolerability, and Pharmacodynamic Efficacy in Participants With Prior Venous Thromboembolism After Completion of Initial Anticoagulant Therapy (Cohort A) and in Cancer Patients at High Risk of Venous Thromboembolism (Cohort B)","Key Inclusion Criteria:\n\nCohort A\n\n1. Adult male and female participants (≥18 years) meeting the specified below criteria for Cohort A.\n2. Postmenopausal women are eligible without additional contraceptive measures.\n\n   Postmenopausal status is defined as:\n   * Age ≥55 years with ≥12 months of spontaneous amenorrhoea, or\n   * Age \\\u003C55 years with ≥12 months of spontaneous amenorrhoea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.\n3. Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period.\n4. Able and willing to provide written informed consent and to comply with trial procedures and follow-up.\n5. Objectively confirmed symptomatic index of the lower limbs at the popliteal vein or more proximal, and\u002For symptomatic PE, documented by objective imaging modalities (eg. DVT: compression ultrasonography\u002Fduplex ultrasound; computed tomography\u002Fmagnetic resonance venography; or contrast venography. PE: computed tomography pulmonary angiography; high probability ventilation\u002Fperfusion scan; or pulmonary angiography).\n6. Completed 3 to 12 months of standard therapeutic anticoagulant therapy for the index VTE episode (vitamin K antagonists, DOACs, low molecular weight heparin, or fondaparinux at therapeutic dose) at least 2 weeks before randomization.\n\nCohort B\n\n1. Adult male and female participants (≥18 years) meeting the specified below criteria for Cohort B.\n2. Postmenopausal women are eligible without additional contraceptive measures.\n\n   Postmenopausal status is defined as:\n   * Age ≥55 years with ≥12 months of spontaneous amenorrhoea, or\n   * Age \\\u003C55 years with ≥12 months of spontaneous amenorrhoea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.\n3. Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period.\n4. Able and willing to provide written informed consent and to comply with trial procedures and follow-up.\n5. Eastern Cooperative Oncology Group performance status 0-2 during screening\n6. Newly diagnosed cancer site or progression of malignant disease, with:\n\n   * No recent chemotherapy or radiotherapy (≤3 months), and\n   * No recent surgery (≤2 weeks).\n   * Histologically or cytologically confirmed active malignancy (solid tumor or lymphoma) requiring initiation of a new systemic cytotoxic chemotherapy course; newly diagnosed disease or documented progression\u002Frecurrence qualifies.\n\nKey Exclusion Criteria:\n\nCohort A\n\n1. Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post-treatment period are not eligible.\n2. Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection at Screening, defined as any of the following:\n\n   * Positive hepatitis B surface antigen (HBsAg), or positive total hepatitis B core antibody (anti-HBc) with detectable HBV DNA;\n   * Positive hepatitis C virus antibody (anti-HCV) with detectable HCV RNA; or\n   * Reactive HIV-1\u002F2 antigen\u002Fantibody test confirmed by a positive confirmatory test.\n\n   Participants who are total anti-HBc-positive must undergo HBV DNA testing, and participants who are anti-HCV-positive must undergo HCV RNA testing. Participants with undetectable HBV DNA or HCV RNA may be eligible provided there is no clinical or laboratory evidence of active liver disease.\n3. Planned surgery that may change VTE\u002Fbleeding risk during the trial period and no recent surgery (≤2 weeks prior screening).\n4. Any serious medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with trial participation, compliance, or interpretation of trial results.\n5. eGFR \\\u003C30 mL\u002Fmin (calculated per CKD-EPI 2021, expected to be reported in mL\u002Fmin per 1.73 m2)\n6. Clear indication for indefinite\u002Fextended anticoagulation for any reason, including but not limited to:\n\n   * Atrial fibrillation or flutter requiring anticoagulation.\n   * Mechanical heart valve or moderate\u002Fsevere rheumatic mitral stenosis.\n   * Recent or ongoing VTE requiring therapeutic anticoagulation (symptomatic or incidental).\n   * Known antiphospholipid syndrome with a high-risk profile, defined as the presence of lupus anticoagulant.\n   * Active cancer requiring anticoagulant prophylaxis or treatment.\n   * Strong thrombophilia (eg, homozygous factor V Leiden, homozygous prothrombin mutation, combined thrombophilias, antithrombin deficiency) where guidelines favor extended anticoagulation.\n\nCohort B\n\n1. Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post treatment period are not eligible.\n2. Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection at Screening, defined as any of the following:\n\n   * Positive hepatitis B surface antigen (HBsAg), or positive total hepatitis B core antibody (anti-HBc) with detectable HBV DNA;\n   * Positive hepatitis C virus antibody (anti-HCV) with detectable HCV RNA; or\n   * Reactive HIV-1\u002F2 antigen\u002Fantibody test confirmed by a positive confirmatory test.\n\n   Participants who are total anti-HBc-positive must undergo HBV DNA testing, and participants who are anti-HCV-positive must undergo HCV RNA testing. Participants with undetectable HBV DNA or HCV RNA may be eligible provided there is no clinical or laboratory evidence of active liver disease.\n3. Planned surgery that may change VTE\u002Fbleeding risk during the trial period and no recent surgery (≤2 weeks prior screening).\n4. Any serious medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with trial participation, compliance, or interpretation of trial results.\n5. eGFR \\\u003C30 mL\u002Fmin (calculated per CKD-EPI 2021, expected to be reported in mL\u002Fmin per 1.73 m2)\n6. High bleeding risk, defined as any of the following:\n\n   * Any condition that, in the investigator's judgment, confers an increased risk of clinically significant bleeding.\n   * Known intracranial malignancy at high hemorrhage risk, defined as known primary brain tumor, or known intracranial metastases with prior intracranial hemorrhage, known hemorrhagic metastases, or other intracranial lesion judged high risk by the investigator (no protocol-mandated screening imaging).\n   * Active or untreated high risk gastrointestinal or GU lesions, including but not limited to active peptic ulcer disease, untreated\u002Fhigh risk esophageal or gastric varices, or GU lesions\u002Ftumors associated with active bleeding (eg, macroscopic hematuria from bladder\u002Furinary tract tumor), unless adequately treated and clinically stabilized.\n   * Clinically overt bleeding (eg, gastrointestinal bleeding, macroscopic hematuria, epistaxis requiring medical attention, or any bleeding requiring an acute care visit) within 4 weeks prior to screening.\n   * Unexplained decrease in hemoglobin ≥2 g\u002FdL within the 2 weeks prior to screening, unless evaluated and a bleeding source has been excluded or treated and clinically stabilized.\n   * Red blood cell transfusion within the 2 weeks prior to screening, unless hemoglobin is clinically stable after correction and there is no evidence of ongoing bleeding (A patient is considered as clinically stabilized if there is no clinically overt bleeding for ≥7 days and no planned urgent endoscopic\u002Furologic intervention for bleeding during the immediate treatment initiation period. A hemoglobin stability is defined as no further decrease \\>1 g\u002FdL over ≥72 hours \\[without additional transfusion\\] with the patient being clinically stable).\n7. Hepatic disease with coagulopathy, including but not limited to:\n\n   * Ascites, cirrhosis, encephalopathy, or jaundice\n   * Hypoalbuminemia \\\u003C3.5 g\u002FdL\n   * Total bilirubin \\>1.5 × ULN\n   * Transaminases \\>2 × the ULN\n   * Biochemical evidence of biliary obstruction\n8. Cancer types not eligible as the sole diagnosis:\n\n   * Basal cell or squamous cell carcinoma of the skin only\n   * Acute leukemia\n   * Myeloproliferative neoplasm","ALL","18 Years",{"count":444,"type":445},150,"ESTIMATED","INTERVENTIONAL",[448],"PHASE2","Blood clots remain a serious cause of illness and death. Long-term treatment and prevention of these clots with blood thinners is often limited by bleeding risk, drug interactions, and daily dosing, leading many patients to stop treatment early. Both cancer and chemotherapy further increase the risk of clot formation.\n\nVortosiran is an injectable therapy that lowers Factor XI (one of the body's natural clotting helpers) production in the liver, leading to a strong and long-lasting reduction in blood clotting activity with less risk of bleeding compared to current available treatments. Studies conducted so far have shown that vortosiran is safe and shows a dose-dependent Factor XI suppression (that is, a higher dose results in a higher level of suppression) that lasts for several months, supporting testing using a limited number of injections in patients who are at higher risk of blod clot formation.\n\nThis study aims to study how safe and effective vortosiran is in patients who have had blood clots in the past and in cancer patients who are at high risk of developing blood clots.",[451,452,453],"Venous Thromboembolism (VTE)","Cancer","Pulmonary Embolism (Diagnosis)",[455,456,457,458,459],"VTE","Venous Thromboembolism","siRNA","Phase 2","RCT","NOT_YET_RECRUITING","2026-09-24",{"date":463,"type":464},"2026-09-30","ACTUAL",{"date":466,"type":445},"2026-10",{"date":468,"type":445},"2028-05",{"name":5,"class":6},30]