27:"/_next/static/immutable/chunks/1caiys5hgvzzo.js" 28:"/_next/static/immutable/chunks/1qmpoydqg-n72.js" 29:I[3292,["$4","$5","$6","$9","$a","$13","$27","$28"],"default"] 2a:T4d2,This is a phase 2, open-label, multicenter study evaluating the efficacy and safety of a fixed-duration combination of epcoritamab, venetoclax, and ibrutinib (EVI) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have TP53 alterations. Patients with TP53 abnormalities, including TP53 mutation and/or 17p deletion, have a poorer prognosis and are less likely to benefit from conventional chemoimmunotherapy. Targeted therapies such as ibrutinib and venetoclax have improved outcomes in this population, but many patients eventually experience disease progression. This study investigates whether adding epcoritamab, a CD3×CD20 bispecific antibody, to the combination of ibrutinib and venetoclax can improve the depth and durability of treatment responses while using a fixed-duration treatment approach. Participants will receive sequential treatment with ibrutinib alone, followed by ibrutinib plus venetoclax, and then the triple combination of epcoritamab, venetoclax, and ibrutinib. The study will evaluate the effectiveness of this regimen, including the achievement of deep remission, as well as its safety and tolerability in this high-risk patient population.2b:T1eff,Inclusion Criteria: 1. Participant who understood and voluntarily signed and dated an informed consent form prior to any trial-specific assessments/procedures being conducted 2. Must be able to adhere to the trial visit schedule and other protocol requirements 3. Age between ≥ 18 years and \< 80 years at the time of signing the informed consent form (ICF) 4. Cumulative Illness Rating Score (CIRS) ≤ 6 5. CD20+, untreated and documented CLL or SLL, with a Royal Marsden Hospital (RMH) or Matutes Score \> 3. For SLL a detectable clone with a CLL phenotype in the peripheral blood is a prerequisite for trial participation. 6. Presence of TP53 abnormalities (either 17p deletion by FISH and/or TP53 mutations) according to ERIC recommandations.17 7. Participant requiring treatment according to 2018 iwCLL guidelines 18 8. Presence of measurable disease (absolute lymphocyte count \> 5,000/μL, palpable or measurable lymph node ≥1.5cm on imaging, or bone marrow involvement 9. ECOG performance status 0 to 2 10. Adequate hematopoietic function within 7 days before the participant's enrollment * ANC ≥ 1 G/L * And Platelets ≥ 50 G/L * And Hemoglobin ≥ 8 g/dL Note: Platelets and/or red blood cells transfusions may be administered during screening to meet this requirement 11. Adequate renal function defined by a Creatinine Clearance ≥ 50 ml/min calculated according to MDRD or CKD-EPI or Cockcroft-Gault (using actual body weight). 12. Adequate liver function, as indicated by a total bilirubin \<1.5 x ULN, AST and ALT \<3 x ULN value, unless directly attributed to the participant's CLL/SLL or to Gilbert's Syndrome (the ULN is based on institutional values) 13. The participant must have been vaccinated against pneumococcal (\< 5 years) and SARS-CoV-2 (\< 1 year) with at least 21 days between the last vaccination and the participant's enrollment 14. Woman of childbearing potential (WOCBP): * should have a negative result for pregnancy test (minimum sensitivity of 25 mIU/mL, urine or serum), within 28 days prior the participant's enrollment * should agree to use 1 form of highly effective method of contraception from the time of screening until at least 12 months after the final dose of epcoritamab, or at least 3 months after the final dose of ibrutinib or at least 30 days after the final dose of venetoclax, whichever is the longest 15. Woman should agree to abstain from breastfeeding during trial participation and at least 4 months after the last study treatment administration 16. Woman should agree to perform further pregnancy testing monthly 17. Woman should agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after the last administration of study treatment. 18. Man of reproductive potential should agree to use an acceptable method of birth control during treatment and until at least 12 months after the final dose of epcoritamab, 3 months after the final dose of ibrutinib and 30 days after the final dose of venetoclax (see section 15.7.3 Acceptable birth control methods). Men should agree not to donate sperm during the entire trial and until 12 months after the last administration of study treatment. 19. Participant covered by any social security system (France) 20. Participant who understands and speaks one of the country official languages unless local regulation authorizes independent translators 21. Life expectancy \> 6 months Exclusion Criteria: 1. Any prior CLL or SLL-specific therapies, even including rituximab used for autoimmune cytopenias. 2. Clinically significant cardiovascular disease including the following: 1. Myocardial infarction within 6 months prior to ICF signature 2. Unstable angina within 3 months prior to ICF signature 3. NYHA class III or IV heart failure 4. Uncontrolled hypertension 5. History of clinically significant arrhythmias (including sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes). 6. QTcF \> 480 msec using the Fridericia formula 7. History of Mobitz II second- or third-degree heart block without permanent pacemaker 8. LVEF \<50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan 3. Child-Pugh liver cirrhosis. 4. Clinical evidence for Central Nervous System involvement by CLL 5. History of ongoing or confirmed Progressive Multifocal Leukoencephalopathy (PML). 6. Active autoimmune disease or other disease requiring permanent immunosuppressive treatment including steroids therapy \> 20mg daily of prednisone dose or equivalent within 15 days prior participant's enrollment 7. Active, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, requiring steroid therapy with \> 20 mg daily of prednisone dose or equivalent within 15 days prior participant's enrollment 8. Any prior history of Richter transformation or DLBCL 9. Active malignancy other than the one treated in this trial. Prior history of malignancies unless the participant has been free of the disease for ≥ 2 years. However, participants with the following history /conditions that have been treated with a curative intent are allowed: 1. Non-invasive basal cell or epidermoid carcinoma (non melanoma) 2. In situ carcinoma of the cervix 3. In situ carcinoma of the breast 4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis \[TNM\] clinical staging system Woman with adjuvant endocrine therapy (I.e., hormonotherapy) after breast cancer treatment can be enrolled if hormonotherapy was started for ≥ 2 years 10. History of stroke or intracranial hemorrhage within 6 months prior to ICF signature. 11. Major surgery anticipated before the ICF signature 12. Known bleeding disorders 13. Active Hepatitis C Virus (HCV) infection (RNA PCR-positive). Participants who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable 14. Active Hepatitis B Virus (HBV) infection (DNA PCR-positive). Participants with evidence of prior HBV infection but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy during the entire treatment with active monitoring of viral load in the blood 15. Known history of seropositivity for HIV infection 16. Known or suspected hypersensitivity or anaphylaxis to trial intervention(s) including active substance or to any of the excipients. 17. Requires treatment with warfarin, other vitamin K antagonists, or dual antiplatelet therapy 18. Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer 19. Vaccinated with live, attenuated vaccines within 6 months of enrollment 20. Participation in another clinical study who would compromise the participation to the current study. 21. Use of any standard or experimental anti-cancer drug therapy within 28 days or 5 half-lives (whichever is shorter) before the participant's enrollment 22. Any prior therapy with a bispecific antibody targeting CD3 and CD20 23. Prior allogeneic stem cells or autologous transplant. 24. Pregnant, planning to become pregnant or lactating woman 25. Any significant medical conditions, or laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical trial (according to the investigator's decision) 26. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of trial drug, including COVID-19 infection and participants with positive cytomegalovirus PCR. 27. Participant deprived of their liberty by a judicial or administrative decision 28. Participant hospitalized without consent 29. Adult participant under legal protection2c:T5c2,Il s'agit d'une étude de phase 2, ouverte et multicentrique, évaluant l'efficacité et la tolérance d'une association à durée fixe d'épcoritamab, de vénétoclax et d'ibrutinib (EVI) chez des patients atteints de leucémie lymphoïde chronique (LLC) ou de lymphome lymphocytique de petite taille (LLP) n'ayant jamais reçu de traitement et présentant des altérations du gène TP53. Les patients présentant des anomalies du gène TP53, notamment une mutation et/ou une délétion 17p, ont un pronostic plus défavorable et sont moins susceptibles de bénéficier d'une chimio-immunothérapie conventionnelle. Les thérapies ciblées telles que l'ibrutinib et le vénétoclax ont amélioré les résultats dans cette population, mais de nombreux patients finissent par présenter une progression de la maladie. Cette étude examine si l'ajout d'épcoritamab, un anticorps bispécifique CD3×CD20, à l'association ibrutinib-vénétoclax peut améliorer la profondeur et la durabilité des réponses au traitement dans le cadre d'une approche thérapeutique à durée fixe. Les participants recevront un traitement séquentiel par ibrutinib seul, suivi d'ibrutinib associé au vénétoclax, puis d'une trithérapie associant épcoritamab, vénétoclax et ibrutinib. L'étude évaluera l'efficacité de ce schéma thérapeutique, notamment l'obtention d'une rémission profonde, ainsi que sa sécurité et sa tolérance chez cette population de patients à haut risque.19:[["$","script",null,{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"MedicalStudy\",\"name\":\"EVITA\",\"url\":\"https://app.klineo.com/fr/trial/NCT07738887\",\"description\":\"Epcoritamab, vénétoclax et ibrutinib chez les patients atteints de leucémie lymphoïde chronique présentant des altérations du gène TP53 Il s'agit d'une étude de phase 2, ouverte et multicentrique, évaluant l'efficacité et la tolérance d'une association à durée fixe d'épcoritamab, de vénétoclax et d'\",\"identifier\":[{\"@type\":\"PropertyValue\",\"propertyID\":\"ClinicalTrials.gov\",\"value\":\"NCT07738887\"},{\"@type\":\"PropertyValue\",\"propertyID\":\"EU CT\",\"value\":\"2025-520893-20-00\"}],\"sponsor\":[{\"@type\":\"Organization\",\"name\":\"AbbVie\"},{\"@type\":\"Organization\",\"name\":\"Johnson & Johnson\"},{\"@type\":\"Organization\",\"name\":\"Lymphoma Study Association\"},{\"@type\":\"Organization\",\"name\":\"The Lymphoma Academic Research Organisation\"}],\"healthCondition\":[{\"@type\":\"MedicalCondition\",\"name\":\"Leucémie lymphoide chronique\"}],\"phase\":\"Phase 2\"}"}}],["$","$L29",null,{"trial":{"id":"4ce5d59f-62d8-4d90-819d-0a5b6d480996","nctId":"NCT07738887","euctId":"2025-520893-20-00","aactOfficialTitle":"Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations","aactBriefSummary":"$2a","aactDescription":"","aactCriteria":"$2b","aactAcronym":"EVITA","aactBriefTitle":"Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations","trialCriterias":[{"id":"55b71b17-35aa-4c7f-82b7-ade2c96c314e","type":"INCLUSION","category":null,"shortDescription":"","description":"1. Participant ayant compris, signé et daté volontairement un formulaire de consentement éclairé avant toute évaluation ou procédure spécifique à l'essai.","isImportant":false},{"id":"38df115f-2253-418e-8d3b-fd69bc92c372","type":"EXCLUSION","category":null,"shortDescription":"","description":"1. Tout traitement antérieur spécifique à la LLC ou au SLL, même le rituximab utilisé pour les cytopénies auto-immunes.","isImportant":false},{"id":"d5040ce1-bdc8-44b2-a33c-163aef9eedee","type":"EXCLUSION","category":null,"shortDescription":"","description":"1. Infarctus du myocarde survenu dans les 6 mois précédant la signature du formulaire ICF","isImportant":false},{"id":"ff3bd4e9-96c1-4ae2-949b-2943ace8961a","type":"INCLUSION","category":null,"shortDescription":"","description":"2. Doit être en mesure de respecter le calendrier des visites d'essai et les autres exigences du protocole.","isImportant":false},{"id":"b95729dc-011a-4d0b-ba66-bcf4572fab43","type":"EXCLUSION","category":null,"shortDescription":"","description":"2. Angine de poitrine instable survenue dans les 3 mois précédant la signature de l'ICF","isImportant":false},{"id":"63c2478f-25a5-4947-8ead-2c7fd967f84b","type":"INCLUSION","category":null,"shortDescription":"","description":"3. Âge compris entre ≥ 18 ans et < 80 ans au moment de la signature du formulaire de consentement éclairé (FCE)","isImportant":false},{"id":"84277d9e-4125-46b4-98aa-89cf3d7ff3c4","type":"EXCLUSION","category":null,"shortDescription":"","description":"3. Insuffisance cardiaque de classe III ou IV selon la NYHA","isImportant":false},{"id":"10ae3f98-c447-4f80-b260-e355b5660bb2","type":"INCLUSION","category":null,"shortDescription":"","description":"4. Score cumulatif d'évaluation de la gravité de la maladie (CIRS) ≤ 6","isImportant":false},{"id":"e2ab3f71-ffcf-43eb-8da4-538660344dd2","type":"INCLUSION","category":null,"shortDescription":"","description":"5. CD20+, LLC ou SLL non traitée et documentée, avec un score Royal Marsden Hospital (RMH) ou Matutes > 3. Pour le SLL, un clone détectable avec un phénotype LLC dans le sang périphérique est une condition préalable à la participation à l'essai.","isImportant":false},{"id":"8c54a9d6-00e3-4682-89ec-3d2fd7ffb4b0","type":"EXCLUSION","category":null,"shortDescription":"","description":"4. Hypertension non contrôlée","isImportant":false},{"id":"b3ac4732-1c82-4072-a08a-01782ffbaee2","type":"INCLUSION","category":null,"shortDescription":"","description":"6. Présence d'anomalies du gène TP53 (délétion 17p par FISH et/ou mutations du gène TP53) conformément aux recommandations ERIC.17","isImportant":false},{"id":"6dc0c695-fc70-48f8-9610-315d1be73b97","type":"EXCLUSION","category":null,"shortDescription":"","description":"5. Antécédents d’arythmies cliniquement significatives (y compris tachycardie ventriculaire soutenue, fibrillation ventriculaire ou torsades de pointes).","isImportant":false},{"id":"da3f643a-2988-4775-8308-fd7a551f9434","type":"EXCLUSION","category":null,"shortDescription":"","description":"6. QTcF > 480 ms selon la formule de Fridericia","isImportant":false},{"id":"3ac8af6c-aa19-4574-8b67-9134ad1ededd","type":"INCLUSION","category":null,"shortDescription":"","description":"7. Participant nécessitant un traitement conformément aux recommandations iwCLL 2018 18","isImportant":false},{"id":"48b91fb3-10e4-4516-8fa1-3bfe0efcd711","type":"INCLUSION","category":null,"shortDescription":"","description":"8. Présence d'une atteinte mesurable (taux absolu de lymphocytes > 5 000/μL, adénopathie palpable ou mesurable ≥ 1,5 cm à l'imagerie, ou atteinte médullaire).","isImportant":false},{"id":"6b3b7d8a-ac2a-42ae-9697-c66ca1403cc6","type":"EXCLUSION","category":null,"shortDescription":"","description":"7. Antécédents de bloc auriculo-ventriculaire de type Mobitz II (deuxième ou troisième degré) sans stimulateur cardiaque permanent","isImportant":false},{"id":"4c02fd04-ca0d-40b3-98fe-20a5f371fe4a","type":"INCLUSION","category":null,"shortDescription":"","description":"9. Score de performance ECOG de 0 à 2","isImportant":false},{"id":"5ccdecfc-2fe2-4cd1-a004-66187799fbea","type":"EXCLUSION","category":null,"shortDescription":"","description":"8. FEVG < 50 % déterminée par échocardiographie ou scintigraphie MUGA (Multiple Uptake Gated Acquisition)","isImportant":false},{"id":"37031548-1072-406e-96b0-7bc2cfa746cc","type":"EXCLUSION","category":null,"shortDescription":"","description":"3. Cirrhose du foie de Child-Pugh.","isImportant":false},{"id":"f3c747d4-12ed-4d43-a938-f37c1eea46e5","type":"INCLUSION","category":null,"shortDescription":"","description":"10. Fonction hématopoïétique adéquate dans les 7 jours précédant l'inclusion du participant\n* ANC ≥ 1 G/L\t\t\n* Et plaquettes ≥ 50 G/L\t\t\n* Et hémoglobine ≥ 8 g/dL","isImportant":false},{"id":"d0d4e0e6-c49d-4a80-a0a7-ba87928a19e9","type":"EXCLUSION","category":null,"shortDescription":"","description":"4. Preuves cliniques d'une atteinte du système nerveux central par la LLC","isImportant":false},{"id":"8e7a17d2-a57c-447c-a734-ba3738338c76","type":"INCLUSION","category":null,"shortDescription":"","description":"11. Fonction rénale adéquate définie par une clairance de la créatinine ≥ 50 ml/min calculée selon MDRD ou CKD-EPI ou Cockcroft-Gault (en utilisant le poids corporel réel).","isImportant":false},{"id":"1c0be015-8317-46f4-b050-e19d8ace63c0","type":"INCLUSION","category":null,"shortDescription":"","description":"12. Fonction hépatique adéquate, comme l'indiquent une bilirubine totale < 1,5 x LSN, et des valeurs d'AST et d'ALT < 3 x LSN, sauf si elles sont directement attribuables à la LLC/SLL du participant ou au syndrome de Gilbert (la LSN est basée sur les valeurs institutionnelles).","isImportant":false},{"id":"b3b98915-31bb-4c93-bd30-0f0834539f80","type":"EXCLUSION","category":null,"shortDescription":"","description":"5. Antécédents de leucoencéphalopathie multifocale progressive (LEMP) en cours ou confirmée.","isImportant":false},{"id":"f2b2990f-2af5-44c9-9ef6-cc068b5de20c","type":"EXCLUSION","category":null,"shortDescription":"","description":"6. Maladie auto-immune active ou autre maladie nécessitant un traitement immunosuppresseur permanent, y compris une corticothérapie à une dose > 20 mg par jour de prednisone ou équivalent dans les 15 jours précédant l'inclusion du participant.","isImportant":false},{"id":"ccb672b0-8c1c-4d8f-a839-d952c866882e","type":"INCLUSION","category":null,"shortDescription":"","description":"13. Le participant doit avoir été vacciné contre le pneumocoque (moins de 5 ans) et le SARS-CoV-2 (moins de 1 an), avec un intervalle d'au moins 21 jours entre la dernière vaccination et l'inscription du participant.","isImportant":false},{"id":"69ce77a6-e67b-43f2-94e2-ed779ceab1f9","type":"EXCLUSION","category":null,"shortDescription":"","description":"7. Anémie hémolytique auto-immune active et non contrôlée ou purpura thrombocytopénique idiopathique, nécessitant un traitement par stéroïdes à une dose quotidienne de > 20 mg de prednisone ou équivalent dans les 15 jours précédant l'inclusion du participant.","isImportant":false},{"id":"ee1ff5b1-71d5-4268-90ed-69c71d21d810","type":"INCLUSION","category":null,"shortDescription":"","description":"* doit présenter un résultat négatif au test de grossesse (sensibilité minimale de 25 mUI/mL, urine ou sérum), dans les 28 jours précédant l'inclusion du participant.","isImportant":false},{"id":"aa55cd87-e591-4776-863b-64d37f2470d0","type":"INCLUSION","category":null,"shortDescription":"","description":"* doivent accepter d'utiliser une méthode contraceptive hautement efficace depuis la sélection jusqu'à au moins 12 mois après la dernière dose d'epcoritamab, ou au moins 3 mois après la dernière dose d'ibrutinib ou au moins 30 jours après la dernière dose de venetoclax, la période la plus longue étant retenue.","isImportant":false},{"id":"0537ecdf-1286-4714-a230-97328d9ecda3","type":"EXCLUSION","category":null,"shortDescription":"","description":"8. Antécédents de transformation de Richter ou de DLBCL","isImportant":false},{"id":"492485a4-3108-4e91-9860-e3d19ef32566","type":"EXCLUSION","category":null,"shortDescription":"","description":"9. Tumeur maligne active autre que celle traitée dans cet essai. Antécédents de tumeurs malignes, sauf si le participant est en rémission depuis au moins deux ans : \n\n1. Carcinome basocellulaire ou épidermoïde non invasif (non mélanome)\t\t\n2. Carcinome in situ du col de l'utérus\t\t\n3. Carcinome in situ du sein\t\t\n4. Découverte histologique fortuite d'un cancer de la prostate (T1a ou T1b) selon le système de classification TNM (tumeur, ganglions, métastases). Les femmes ayant reçu une hormonothérapie adjuvante après un traitement pour un cancer du sein peuvent être incluses si l'hormonothérapie a été instaurée depuis au moins deux ans.","isImportant":false},{"id":"083d2801-efaf-4f97-a70c-8d36571f3a18","type":"INCLUSION","category":null,"shortDescription":"","description":"15. La femme doit s'engager à ne pas allaiter pendant toute la durée de l'essai et pendant au moins 4 mois après la dernière administration du traitement.","isImportant":false},{"id":"f2011054-d1d4-4097-a5e5-7237ed31a4d3","type":"INCLUSION","category":null,"shortDescription":"","description":"16. La femme doit accepter de se soumettre à des tests de grossesse mensuels.","isImportant":false},{"id":"79ae7757-a315-473a-84fa-28c4a054e74c","type":"EXCLUSION","category":null,"shortDescription":"","description":"10. Antécédents d'accident vasculaire cérébral ou d'hémorragie intracrânienne dans les 6 mois précédant la signature du formulaire ICF.","isImportant":false},{"id":"cee74303-9072-427d-acb5-dc4c07f5667d","type":"INCLUSION","category":null,"shortDescription":"","description":"17. La femme doit accepter de ne pas donner d’ovules (ovocytes) à des fins de procréation assistée pendant toute la durée de l’essai, jusqu’à 12 mois après la dernière administration du traitement à l’étude.","isImportant":false},{"id":"5a0661bd-cdfd-4cfe-a7fa-39dac2d478a5","type":"EXCLUSION","category":null,"shortDescription":"","description":"11. Intervention chirurgicale majeure prévue avant la signature du CFI","isImportant":false},{"id":"dad7e24a-f21f-400d-ba01-7d8516fd14c1","type":"EXCLUSION","category":null,"shortDescription":"","description":"12. Troubles hémorragiques connus","isImportant":false},{"id":"51dff871-062e-484f-9051-d0f1dec7cfa4","type":"INCLUSION","category":null,"shortDescription":"","description":"18. Les hommes en âge de procréer doivent s’engager à utiliser une méthode contraceptive efficace pendant le traitement et jusqu’à au moins 12 mois après la dernière administration d’epcoritamab, 3 mois après la dernière administration d’ibrutinib et 30 jours après la dernière administration de venetoclax (voir rubrique 15.7.3 Méthodes contraceptives efficaces). Ils doivent également s’engager à ne pas faire de don de sperme pendant toute la durée de l’essai et jusqu’à 12 mois après la dernière administration du traitement expérimental.","isImportant":false},{"id":"d0d0db6c-1574-4646-8ac7-9362b3f043c8","type":"EXCLUSION","category":null,"shortDescription":"","description":"13. Infection active par le virus de l'hépatite C (VHC) (ARN PCR positif). Les participants ayant reçu un traitement contre l'infection par le VHC visant à éradiquer le virus peuvent participer si les niveaux d'ARN du virus de l'hépatite C sont indétectables.","isImportant":false},{"id":"f449fedb-ae66-466c-af9f-7e13abfa4eb7","type":"INCLUSION","category":null,"shortDescription":"","description":"19. Participant couvert par un système de sécurité sociale (France)","isImportant":false},{"id":"adde2c76-0f2d-494f-9c22-c2c6c1829844","type":"EXCLUSION","category":null,"shortDescription":"","description":"14. Infection active par le virus de l'hépatite B (VHB) (PCR ADN positive). Les participants présentant des antécédents d'infection par le VHB, mais dont la PCR est négative, sont autorisés à participer à l'essai. Ils doivent cependant recevoir un traitement antiviral prophylactique pendant toute la durée du traitement, avec une surveillance active de la charge virale dans le sang.","isImportant":false},{"id":"b8f7e34e-c94d-4a41-a9b0-834944370e0e","type":"INCLUSION","category":null,"shortDescription":"","description":"20. Participant qui comprend et parle l'une des langues officielles du pays, sauf si la réglementation locale autorise le recours à des traducteurs indépendants.","isImportant":false},{"id":"5bd287c0-15bb-4575-9560-bd0672259499","type":"INCLUSION","category":null,"shortDescription":"","description":"21. Espérance de vie > 6 mois","isImportant":false},{"id":"c53c4bb8-043b-4adf-9f89-fac1e20d0a76","type":"EXCLUSION","category":null,"shortDescription":"","description":"15. Antécédents connus de séropositivité à l'infection par le VIH","isImportant":false},{"id":"00cfe0fe-f798-4f91-8d9a-9bc3ed37167b","type":"EXCLUSION","category":null,"shortDescription":"","description":"16. 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