[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-cirrhosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100638473","phase-2-study-of-azd2389-safety-tolerability-and-pharmacodynamics-in-adults-with-steatotic-liver-disease-and-advanced-fibrosis-100638473",false,"NCT07610837","Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis","A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)","BRAVO","Key Inclusion Criteria:\n\n* Males\u002Ffemales aged 18 or over\n* A diagnosis of SLD with advanced fibrosis\n* No significant change in weight over the last 6 months\n* Contraceptive us by participants or participants partners\n* Capable of giving informed consent\n* Judged by the investigator to be suitable for study\n\nKey Exclusion Criteria:\n\n* Portal hypertension (LSM \\>25 kPa or 20-25 kPa with platelets \\\u003C150×10⁹\u002FL), decompensated liver disease, Child-Pugh \\>A6, MELD \\>12, other chronic liver diseases, prior\u002Fplanned liver transplant, or malignant liver tumors.\n* Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.\n* Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.\n* Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac\u002Fcerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.\n* History of psychosis, bipolar disorder, recent major depression, or suicide attempt\u002Fideation within 1 year.\n* Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.\n* Prohibited medications or hypersensitivities, including moderate\u002Fstrong CYP3A4 or BCRP\u002FOAT3 inhibitors\u002Finducers, anticoagulants\u002Fantiplatelets (except aspirin ≤81 mg\u002Fday), or hypersensitivity to DPP4 inhibitors.\n* Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT\u002FAST), recent participation in another IMP study, or investigator judgment of unsuitability.","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.",[27,28],"Liver Fibrosis","Hepatic Cirrhosis",[27,28],"RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":34},"2026-05-07",{"date":38,"type":21},"2027-07-07",{"name":40,"class":41},"AstraZeneca","INDUSTRY",20,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100567140","evaluation-of-the-efficacy-and-safety-of-portal-pressure-gradient-ppg-measurement-guided-by-endoscopic-ultrasound-eus-in-the-therapeutic-algorithm-of-patients-with-liver-cirrhosis-100567140","NCT06664307","Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.","GPP-USE","Inclusion Criteria:\n\n* Patients diagnosed with advanced liver disease with an indication for primary prophylaxis with NSBBs\n\nExclusion Criteria:\n\n\\- Age \\\u003C 18 years. 2. Advanced stage hepatocellular carcinoma not eligible for curative treatment. 3. Pregnancy. 4. Esophageal stenosis. 5. INR \\> 1.5. 6. Platelets \\\u003C 50,000 µL. 7. Ascites. 8. Patients with any contraindication for performing an upper gastrointestinal endoscopy.\n\n9\\. Patients with contraindication to NSBB treatment. 10. Refusal to sign the informed consent form to participate in the study","85 Years",{"count":52,"type":21},35,"OBSERVATIONAL","The development of Clinical significant PH (CSPH) is a major driver of complications. PPG is the strongest predictor of decompensation . The shortcomings of GPVH measurements and invasiveness has resulted in an area of unmet clinical need. Non-selective beta-blockers (NSBB) have demonstrated efficacy in reducing PH. However, this requires a second invasive procedure, and there is high interindividual variability in the hemodynamic response to NSBB. EUS-guided GPP measurement emerges as a more accurate, accessible and less invasive technique to potentially predict chronic hemodynamic response. The aim of this project is to assess the safety and efficacy of EUS-derived GPP measurement (EUS-GPP) in patients diagnosed with cirrhosis, to assess the acute hemodynamic response through EUS-derived GPP to intravenous propranolol administration in order to determine the patients who would benefit from NSBB treatment in primary prophylaxis to prevent decompensation using a strategy guided by EUS-GPP measurement.",[56,28],"Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS)",[58],"Portal pressure gradient (PPG), endoscopic ultrasound (EUS) ,.the acute hemodynamic response","NOT_YET_RECRUITING","2024-10-28",{"date":62,"type":34},"2024-10-29",{"date":64,"type":21},"2024-11-01",{"date":66,"type":21},"2027-11-01",{"name":68,"class":69},"Hospital Universitario Virgen Macarena","OTHER",1]