[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,66,95,120,159,180,205,228],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100641002","phase-2-phoenix-ecp--extracorporeal-photopheresis-for-immune-related-colitis-andor-hepatitis-in-advanced-melanoma-with-inadequate-response-to-steroid-exposure-100641002",false,"NCT07619898","PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and\u002For Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure","PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety\u002FTolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)","PHOENIX-ECP","Inclusion Criteria:\n\n1. Participants diagnosed with unresectable or metastatic melanoma ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.\n2. Participants diagnosed with ir-colitis and\u002For ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (\n3. Participants with endoscopic evidence of ir-colitis\n4. Participants with inadequate response to corticosteroids, as defined per protocol\n5. Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Presence of irAEs in addition to and other than ir-colitis and\u002For ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis\u002Fir-hepatitis) based on ASCO guidelines.\n2. Participant has a diagnosis of uveal melanoma as the sole melanoma subtype\n3. Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids\n4. Concurrent conditions which may require treatment with high dose corticosteroid (\\> 1 milligram per kilogram per day \\[mg\u002Fkg\u002Fday\\]) and interfere with the corticosteroid tapering schedule recommended by the protocol.\n5. Pre-existing liver disease\n6. Active alcohol use disorder\n7. Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.\n8. Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.\n9. Contraindications or known allergic reaction to any of study intervention and\u002For procedures\n10. Participants unable to tolerate the fluid shift associated with the ECP procedure.\n11. Positive result for active or previous viral infections: covid-19, hepatitis B\u002FC, CMV, EBV, adenovirus\n12. History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.","ALL","18 Years",{"count":20,"type":21},112,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.\n\nImmune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately.\n\nThe purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.",[27,28,29],"Colitis","Hepatitis","Melanoma (Skin Cancer)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,27,51,52,53],"Melanoma","Immune-related adverse events","Immune-related colitis","Immune checkpoint inhibitor toxicity","Checkpoint inhibitor-induced colitis","Checkpoint inhibitor-induced hepatitis","Metastatic melanoma","Unresectable melanoma","Immune checkpoint Inhibitors","Extracorporeal photopheresis","ECP","UVADEX","Device","Methoxsalen","Steroid-refractory","Corticosteroid refractory","Phase 2 clinical trial","Randomized controlled trial","Cellex","8-Mop","Ir-AE","Ir-AE Colitis","Ir-AE Hepatitis","NOT_YET_RECRUITING","2026-05-27",{"date":57,"type":58},"2026-06-02","ACTUAL",{"date":60,"type":21},"2026-07",{"date":62,"type":21},"2029-12",{"name":64,"class":65},"Therakos LLC","INDUSTRY",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100625892","phase-3-study-to-evaluate-the-safety-and-efficacy-of-larsucosterol-in-participants-with-alcohol-associated-hepatitis-ah-100625892","NCT07428538","Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)","RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)","Inclusion Criteria-\n\nA participant will be eligible for inclusion in this study if he\u002Fshe meets all the following criteria:\n\n1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).\n2. Onset of jaundice within 8 weeks before hospital admission.\n3. Average daily consumption of greater than (\\>) 40 (females) or \\>60 (males) grams alcohol for 6 months or longer, with less than (\\\u003C) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.\n4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):\n\n   1. Serum total bilirubin \\>3.0 milligrams per deciliter (mg\u002FdL) (required at randomization)\n   2. ALT \\\u003C400 international unit per Liter (IU\u002FL) (required at randomization)\n   3. 50 \\\u003CAST \\\u003C400 IU\u002FL\n   4. AST \\\u003C400 IU\u002FL (required at randomization)\n   5. AST \\>50 IU\u002FL (at any time since current hospital admission or leading to this current hospitalization)\n   6. AST\u002FALT \\>1.5 (at any time since current hospital admission or leading to this current hospitalization)\n5. Maddrey discriminant function (MDF) \\>=32, assuming a control prothrombin time of 12 seconds.\n\n   NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time\u002FINR.\n6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).\n7. Male or female participants 18 years of age or older.\n8. Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills (\"The Pill\") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.\n9. Male participants must agree to use a medically acceptable method of contraception\u002Fbirth control and refrain from sperm donation throughout the 90-day portion of the study.\n10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.\n11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)\n\nExclusion Criteria-\n\nA participant will be excluded from the study if he or she meets any of the following criteria:\n\n1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.\n\n   NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial\n2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.\n3. Active infection (such as spontaneous bacterial peritonitis \\[SBP\\], urinary tract infection \\[UTI\\], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).\n\n   1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.\n   2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.\n   3. Participants with systemic fungal infection of any kind cannot be considered for this trial.\n4. Serum creatinine \\>2.5 mg\u002FdL.\n5. Participants undergoing continuous veno-venous hemodialysis (CVVH).\n6. Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.\n7. TIPS insertion or variceal embolization within the last 4 weeks.\n8. Known portal vein occlusion.\n9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.\n10. Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.\n11. Stage \\>=3 hepatic encephalopathy by West Haven criteria.\n12. Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to \\[\\\u003C=\\] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to:\n\n    1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association \\[NYHA\\] Class III or IV heart failure)\n    2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc \\>=500 msec, or high-grade AV block)\n    3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] Stage III or IV chronic obstructive pulmonary disease \\[COPD\\])\n    4. End-stage renal disease requiring chronic, ongoing dialysis\n    5. Severe uncontrolled endocrine or metabolic disorders\n    6. Severe psychiatric illness likely to interfere with study participation\n    7. Hypotension\u002Fshock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure \\[MAP\\] \\\u003C60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output)\n13. Other concomitant cause(s) of liver disease as a result of:\n\n    1. Autoimmune liver disease\n    2. Ischemic hepatitis\n    3. Wilson disease or alpha 1 antitrypsin deficiency\n    4. Vascular liver disease (e.g., Budd-Chiari)\n    5. Drug induced liver disease\n    6. Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing \\>4 weeks is anticipated.\n    7. Acute hepatitis A (if test performed per SOC)\n    8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded\n    9. Acute hepatitis E (if test performed per SOC)\n    10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)\n14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).\n15. Existing or intended pregnancy or breast feeding.\n16. Participation in another interventional clinical trial within 30 days of Screening.\n17. History of organ transplantation other than corneal transplant.\n18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.\n19. Participant listed for liver transplant (LT) prior to study drug administration.\n20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.",{"count":74,"type":21},350,[76],"PHASE3","The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.",[28],[80,81,82,83],"Alcoholic hepatitis","alcohol-associated liver disease (ALD)","Liver transplant (LT)","Alcohol-associated hepatitis (AH)","RECRUITING","2026-05-05",{"date":87,"type":58},"2026-05-07",{"date":89,"type":58},"2026-01-29",{"date":91,"type":21},"2028-02",{"name":93,"class":65},"Bausch Health Americas, Inc.",48,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100626986","epro-diary---hdv--macroliver--100626986","NCT07442760","ePro Diary - HDV ( MACROLIVER )","The Patient is the Main Protagonist of His Care Journey","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of Delta infection (anti-HDV positivity)\n* Signed informed consent\n* Ability to adequately understand instructions for correctly using mobile device applications.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.",{"count":103,"type":21},55,"OBSERVATIONAL","This study is part of the MACROLIVER Project, which aims to develop a digital tool for patients and their caregivers to manage liver diseases. Approximately 20-25 million individuals worldwide carry HBsAg and are co-infected with HDV, though geographic variations exist. In Italy, an estimated 10,000-20,000 individuals are affected by Delta hepatitis (HD). These data are approximate, given the absence of current population studies and effective screening methods.\n\nAlthough considered rare, chronic HD (CHD) is the most aggressive form of viral hepatitis, with most patients progressing rapidly to end-stage liver disease or developing hepatocellular carcinoma at a young age, often requiring liver transplantation. Screening HBsAg-positive patients for Delta co-infection is not widespread, leading to late diagnoses. Additionally, accurate quantification of viral RNA is limited to a few specialized centers.\n\nThe lack of effective antiviral therapies has led many Delta hepatitis patients to frequently switch hepatology centers in search of treatments or to miss regular medical check-ups. However, HDV management may change significantly following the recent EMA approval of a new antiviral drug, bulevirtide-an entry inhibitor administered subcutaneously daily-reimbursed in Italy since April 2023. This drug has shown promising results in Phase II and III studies, including in cirrhotic patients with severe portal hypertension.\n\nThe COVID-19 pandemic exacerbated this situation, causing reduced access to healthcare facilities and negatively impacting patients with chronic diseases. However, it also accelerated the search for effective, high-quality digital solutions for patient management.\n\nThe ePro-Diary HDV proposes to facilitate continuous communication between patients and doctors, monitor key lab values, quality of life questionnaires, and overall health status by an application for mobile phone.\n\nThe objectives are twofold: to make patients active participants in their care-enhancing retention and adherence through an \"active App-based approach\"-and to evaluate changes in patient quality of life with this \"active\" remote approach. This tool will support clinicians and patients without replacing standard clinical monitoring.",[107,108,28],"HDV","HDV Infection","2026-02-24",{"date":111,"type":58},"2026-03-02",{"date":113,"type":58},"2025-03-31",{"date":115,"type":21},"2030-03-31",{"name":117,"class":118},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS","OTHER",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100546453","low-dead-space-injecting-equipment-distribution-program-for-people-who-inject-drugs-in-low--and-middle-income-countries-100546453","NCT06395129","Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries","Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation","Inclusion Criteria:\n\n* Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant);\n* Reporting a history of recent (past month) injection drug use;\n* Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID;\n* Able to understand and communicate in the local language(s);\n* If self-reporting HCV\u002FHIV negative status, interested in and agreeing to undergo HCV and HIV testing; and\n* Willing and able to provide informed consent to take part in the study.\n\nExclusion Criteria:\n\n* N\u002FA",true,{"count":129,"type":21},2400,"Implementation and evaluation of a distribution program for low dead-space syringes\u002Fneedles (LDSS\u002FN) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS\u002FN distribution programs which will enhance acceptability and sustain high levels of LDSS\u002FN uptake.\n\nPeople who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS\u002FN.\n\nThroughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program.\n\nPrimary outcomes assessed through this study include 1) community values and preferences for LDSS\u002FN, 2) barriers and facilitators to accessing LDSS\u002FN, 3) feasibility and effectiveness of the distribution program on increasing LDSS\u002FN uptake, 4) model the potential public health impact and cost effectiveness of LDSS\u002FN distribution in this setting.",[132,28,133],"Drug Use","Hiv",[135,136,137,138,139,140,141,142,143,144,145,146,147,148],"Low dead-space needles and syringes","Qualitative interviews","LDSS\u002FN","High dead space needles\u002Fsyringes (HDSS\u002FN)","Rapid diagnostic test (RDT)","Feasibility","Acceptability","Cost effectiveness","Modelling","Focus group discussions","Harm Reduction","Values and preferences","Needle and syringe exchange program","Blood borne virus","2025-09-25",{"date":151,"type":58},"2025-10-01",{"date":153,"type":58},"2024-09-13",{"date":155,"type":21},"2026-12",{"name":157,"class":118},"Médecins du Monde",9,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":119},"100560041","conventional-ultrasound-versus-remote-ultraportable-ultrasound-in-the-context-of-viral-hepatitis-100560041","NCT06571981","Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis","Comparison Between Conventional Ultrasound and Remote Ultraportable ulTrasound for Abdominal Examination in the Context of Viral Hepatitis","RUTH","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* All adult patients with viral hepatitis for which an ultrasound is planned\n\nExclusion Criteria:\n\n* Known or suspected non-compliance\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,\n* Previous enrollment into the current study",{"count":168,"type":21},102,"Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)",[28,171],"Teleradiology",{"date":173,"type":58},"2025-04-03",{"date":175,"type":58},"2024-11-01",{"date":177,"type":21},"2025-12-31",{"name":179,"class":118},"Naik Vietti Violi",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":119},"100515319","phase-1-the-safety-tolerability-and-efficacy-study-of-hepacure-in-chinese-subjects-with-acute-on-chronic-liver-failure-100515319","NCT05989958","The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure","A Multicenter, Randomized, Controlled, Open-Label Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure","Inclusion Criteria:\n\n1. Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.\n2. Age: ≥ 18 years and ≤ 65 years.\n3. Body weight: ≥ 40kg;\n4. Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol\u002FL or increase ≥ 17.1 μmol\u002FL daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%\\\u003CPTA ≤ 40% (or 1.5 ≤ INR\\\u003C2.6), and other reasons excluded.\n\nExclusion Criteria:\n\n1. Subjects with primary or metastatic liver cancer.\n2. Subjects with severe esophageal\u002Fgastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.\n3. Serum creatinine was greater than 132.6 μmol\u002FL.\n4. Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases\u002FAmerican Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites\\>0.1 × 10 9\u002FL after reasonable antibiotic treatment), etc;","65 Years",{"count":189,"type":21},92,[191,24],"PHASE1","This is a multicenter, randomized, controlled, open-label phase 1\u002F2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）.\n\nPhase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.\n\nPhase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects",[194,195,28],"Acute on Chronic Hepatic Failure","Liver Failure","2025-02-21",{"date":198,"type":58},"2025-02-25",{"date":200,"type":58},"2023-09-22",{"date":202,"type":21},"2026-09",{"name":204,"class":65},"Hexaell Biotech Co., Ltd.",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100574590","acute-hepatitis-in-pediatrics-100574590","NCT06761261","Acute Hepatitis in Pediatrics","LIVERPED","Inclusion Criteria:\n\n* Age between 0 and 17 years (extremes included).\n* Access to PSP and\u002For hospitalized (OBI or hospitalization)\n* Diagnosis of acute hepatitis\n\nExclusion Criteria:\n\n* Refusal of the parent\u002Fguardian to participate in the study.\n* Mild hypertransaminasemia (\\<5 times the upper limit of normal) in a patient with known chronic liver dysfunction (e.g. liver cirrhosis).\n* Neonatal jaundice without hepatocyte involvement or signs of cholestasis (prevalence of indirect bilirubin with normal AST, ALT and GGT).","17 Years",{"count":214,"type":21},437,"This study aims to investigate wich symptoms and blood test characteristics acute hepatitis manifests in pediatric age. The study will be conducted because acute hepatitis is not an easily and clearly recognized disease in children.\n\nThis study aims to better characterize this disease by describing the frequency of the different symptoms with which it can manifest and the changes it causes in blood tests. It also aims to assess the occurrence of any complications of pediatric acute hepatitis.\n\nThe study is observational, so it is limited to collecting data and analyzing the patient's clinical course without interfering with normal clinical practice.",[28],[28],"2024-12-30",{"date":220,"type":58},"2025-01-07",{"date":222,"type":58},"2023-10-16",{"date":224,"type":21},"2028-12-31",{"name":226,"class":118},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",2,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":235,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":119},"100482086","phase-2-to-evaluate-the-efficacy-and-safety-of-tynadote-in-the-treatment-of-acetaminophen-overdose-100482086","NCT05557448","To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose","An Exploratory Study to Evaluate the Efficacy and Safety of TYNADOTE® Combined N-acetylcysteine in the Treatment of Acetaminophen Overdose","Inclusion Criteria:\n\n* Poisoning and hospitalized patients taking acetaminophen.\n* Acute ingestion of more than 150 mg\u002Fkg or plasma concentration of Acetaminophen is above the treatment line on single acute acetaminophen overdose nomogram.\n* Male or female with age more than 20 years at Screening.\n* Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments.\n\nExclusion Criteria:\n\n* Subjects with Sequential Organ Failure Assessment (SOFA) Score higher than 12.\n* Subjects who fulfilled the King's College Hospital (KCH) Criteria for liver transplantation.\n* Subjects who was conscious disturbance.\n* History of allergic response(s) to N-acetylcysteine (NAC), mannitol, sucralose or related drugs.\n* Subject who was unable to take medicine by oral route.\n* Receiving any investigational drug within 30 days prior to first dosing.\n* Subject who had attacked asthma or bronchitis combined with medication therapy within six months prior to enrollment.\n* Donating greater than 150 mL of blood within two months prior to first dosing or donating plasma (e.g. plasmapheresis) within 14 days prior to first dosing. All subjects will be advised not to donate blood for four weeks after completing the study.\n* Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at baseline.\n* Anuria, pulmonary congestion, severe congestive heart failure, brain hemorrhage, or any conditions that in the opinion of the investigator may interfere with the evaluation of study objectives.\n* The combination of poisoning contains acetaminophen and other compound.\n* Body weight less than 50 kg.","20 Years",{"count":237,"type":21},24,[24],"To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose",[28],[242,243,244,245,246],"Paracetamol","Acetaminophen","Acute liver failure","N-acetylcysteine","Acetaminophen overdose","2024-01-09",{"date":249,"type":58},"2024-01-10",{"date":251,"type":58},"2023-05-01",{"date":155,"type":21},{"name":254,"class":65},"Sinew Pharma Inc."]