[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Can-Fite BioPharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":141},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,68,97,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624501","phase-2-an-open-label-phase-2-pilot-study-on-the-efficacy-and-safety-of-piclidenoson-in-patients-with-lowe-syndrome-100624501",false,"NCT07410455","An Open-label, Phase 2 Pilot Study on the Efficacy and Safety of Piclidenoson in Patients With Lowe Syndrome","Inclusion Criteria:\n\n* Males 18 years and above;\n* Documentation of genetically-proven Lowe Syndrome;\n* Estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73m2, as calculated by the CKD-EPI equation;\n* Male subjects must refrain from sperm donation during treatment and until at least 1 month after the last dose of study medication. Male subjects must agree to use condoms throughout the course of the trial and for 1 month after the last dose of study medication;\n* Ability to complete the study in compliance with the protocol; and\n* Ability to understand and provide written informed consent (subject or legal guardian).\n\nExclusion Criteria:\n\n* Subjects receiving chronic therapies not related to Lowe syndrome; Estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m2 by the CKD-EPI equation;\n* Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal;\n* QTcF interval \\> 450 milliseconds (msec) on ECG (average of triplicate ECGs) (except when QT prolongation is associated with right or left bundle branch block or cardiac pacemaker, in which case enrollment is allowed);\n* A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome;\n* Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes; https:\u002F\u002Fcrediblemeds.org\u002F;\n* Active gastrointestinal disease which could interfere with the absorption of oral medication;\n* Active drug or alcohol dependence;\n* Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine;\n* Significant acute or chronic medical or psychiatric illness, including chronic systemic infection or malignancy, that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and\u002For compromise the objectives of the study; and\n* Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.","MALE","18 Years",{"count":5,"type":18},"ESTIMATED","INTERVENTIONAL",[21],"PHASE2","The primary objective of this trial is to:\n\n1\\. Evaluate the efficacy of piclidenoson to increase renal uptake of 99mTc-labeled DMSA, in comparison to baseline, after 6 months (26 weeks) of treatment as a measure the reabsorption capacity of LMWPs by renal proximal tubules.\n\nThe secondary objectives of this trial are to:\n\n1. Evaluate changes in urinary excretion of LMWPs and other clinical parameters of renal Fanconi syndrome\n2. Evaluate safety of piclidenoson in patients with Lowe syndrome",[24],"Lowe Syndrome",[24,26,27,28],"Piclidenoson","CF101","Can-Fite","NOT_YET_RECRUITING","2026-02-15",{"date":32,"type":33},"2026-02-18","ACTUAL",{"date":35,"type":18},"2026-06-01",{"date":37,"type":18},"2027-08-31",{"name":39,"class":40},"Can-Fite BioPharma","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":19,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100565521","phase-3-a-phase-3-study-in-moderate-to-severe-plaque-psoriasis-with-piclidenoson-to-study-safety-and-efficacy-100565521","NCT06643260","A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Male or female, 18 years and above;\n2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%;\n3. PASI score ≥12 at the Screening and Baseline visits;\n4. Static PGA ≥3 at the Screening and Baseline visits;\n5. Candidate for systemic treatment or phototherapy for psoriasis;\n6. Duration of psoriasis of at least 12 months;\n7. Females of childbearing potential must have a negative serum pregnancy test at screening;\n8. Female subjects of childbearing potential must use at least one acceptable contraceptive method throughout the course of the trial and for 1 month after the last dose of study medication;\n9. Male subjects must refrain from sperm donation during treatment and until at least 1 month after the last dose of study medication. Male subjects must agree to use condoms throughout the course of the trial and for 1 month after the last dose of study medication;\n10. Ability to complete the study in compliance with the protocol; and\n11. Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n1. Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis;\n2. Treatment with systemic retinoids, systemic corticosteroids, tofacitinib, apremilast, immunosuppressive agents (e.g., methotrexate, cyclosporine), or any other approved drugs for the indication of plaque psoriasis (e.g., deucravacitinib) within 4 weeks of the Baseline visit;\n3. Treatment with a monoclonal antibody or other biologic agent for psoriasis within 8 weeks for etanercept, adalimumab, or infliximab, or within 12 weeks for all other agents, prior to the Baseline visit;\n4. Treatment with Vitamin D analogs, keratolytics, coal tar (other than on the scalp, palms, groin, and\u002For soles), any topical corticosteroid, calcineurin inhibitors, vitamin A analogs, retinoids, anthralin, calcipotriene, tazarotene, methoxsalen, trimethyl-psoralens, fumarate, PDE4 inhibitors, or aryl hydrocarbon receptor-modulating agents within 2 weeks of the Baseline visit;\n5. Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;\n6. Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period, unless dose has been stable for 3 months prior to the Screening visit and will remain stable throughout the trial;\n7. Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2 by the Modification of Diet in Renal Disease equation at Screening (NOTE: In Segment 2, a renally-impaired subgroup of at least 10 12 subjects with eGFR of 20-49 mL\u002Fmin\u002F1.73m2 will be enrolled for PK analysis purposes);\n8. Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal at Screening;\n9. QTcF interval \\> 450 milliseconds (msec) for males or \\> 470 msec for females on Screening Visit and Baseline visit ECGs (average of triplicate ECGs at each visit) (except when QT prolongation is associated with right or left bundle branch block or cardiac pacemaker, in which case enrollment is allowed);\n10. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome;\n11. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes;\n12. Active gastrointestinal disease which could interfere with the absorption of oral medication;\n13. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;\n14. Active drug or alcohol dependence;\n15. Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine;\n16. PHQ-9 score ˃ 4 at baseline;\n17. Any significant\u002Funcontrolled neuropsychiatric illness judged as clinically significant by the investigator during screening or at Day 1, or any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by medical history or by Columbia Suicide Severity Rating Scale (C-SSRS) documentation, or by answering \"yes\" to Question 4 or 5 for suicidal ideation on the C-SSRS at screening or at Day 1, or is clinically deemed to have a suicide risk by the investigator;\n18. Previous participation in a piclidenoson (CF101) clinical trial;\n19. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and\u002For compromise the objectives of the study; and\n20. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.","ALL",{"count":51,"type":18},705,[53],"PHASE3","This is a double-blind, placebo-controlled study in adults with a diagnosis of moderate-to-severe chronic plaque psoriasis to test the efficacy and safety of piclidenoson in this patient population.",[56],"Plaque Psoriasis",[58,59],"Psoriasis","Plaque psoriasis","2025-04-28",{"date":62,"type":33},"2025-04-29",{"date":64,"type":18},"2025-06",{"date":66,"type":18},"2028-06",{"name":39,"class":40},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":19,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100454735","phase-3-namodenoson-in-the-treatment-of-advanced-hepatocellular-carcinoma-in-patients-with-child-pugh-class-b7-cirrhosis-100454735","NCT05201404","Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","LIVERATION","Inclusion Criteria:\n\n1. Males and females at least 18 years of age.\n2. Diagnosis of HCC:\n\n   * For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable).\n   * For patients with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Marrero 2018).\n3. HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.\n4. HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.\n5. Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).\n6. Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.\n7. Measurable disease by RECIST v1.1 (Eisenhauer 2009).\n8. ECOG PS of ≤ 1.\n9. Cirrhosis classified as CPB7; if ascites is used as a scoring criterion, it must be classified as Grade ≥2 by the Clinical Practice Guidelines of the European Association for the Study of the Liver (EASL 2010).\n10. The following laboratory values must be documented within ten days prior to the first dose of study drug:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n    * Platelet count at least 75 × 10\\^9\u002FL\n    * Creatinine clearance at least 50 mg\u002FdL (estimated glomerular filtration rate by the Cockcroft-Gault or the Modification of Diet in Renal Disease methods)\n    * AST and ALT ≤ 5 × the upper limit of normal (ULN)\n    * Total bilirubin ≤ 3.0 mg\u002FdL\n    * Serum albumin ≥ 2.8 g\u002FdL.\n11. Life expectancy of ≥ 6 weeks.\n12. For women of childbearing potential, negative serum pregnancy test result.\n13. Provide written informed consent to participate.\n14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.\n\nExclusion Criteria:\n\n1. Receipt of \\>2 prior systemic drug therapies for HCC.\n2. Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids \\> 20 mg\u002Fday prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.\n3. Locoregional treatment within 4 weeks prior to the Baseline Visit.\n4. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.\n5. Use of any investigational agent within 4 weeks prior to the Baseline Visit.\n6. Concomitant use of P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) inhibitors and\u002For substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product (see Section 12.2).\n7. Child-Pugh Class A, B8\u002F9, or C cirrhosis.\n8. Hepatic encephalopathy.\n9. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.\n10. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.\n11. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.\n12. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.\n13. Liver transplant.\n14. Active malignancy other than HCC.\n15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).\n16. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.\n17. History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \\> 470 msec (patients with bundle branch block will not be excluded for QTc reasons).\n18. Pregnant or lactating female.\n19. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug.\n20. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.\n21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and\u002For with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.",{"count":77,"type":18},471,[53],"This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.",[81,82],"Hepatocellular Carcinoma","Cirrhosis",[84,85,86,87,88],"Hepatocellular carcinoma","HCC","Liver cancer","Child-Pugh Class B7 cirrhosis","CPB7","RECRUITING",{"date":62,"type":33},{"date":92,"type":33},"2023-03-15",{"date":94,"type":18},"2026-10",{"name":39,"class":40},32,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":19,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":41},"100545855","phase-2-namodenoson-treatment-of-advanced-pancreatic-cancer-100545855","NCT06387342","Namodenoson Treatment of Advanced Pancreatic Cancer","CF102-222PC: A Phase 2 Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Males and females at least 18 years of age.\n2. Histologically or cytologically confirmed pancreatic adenocarcinoma, or clinically diagnosed based upon scan results and a serum Cancer Antigen 19-9 value \\>1000 U\u002FmL on at least 1 occasion.\n3. Pancreatic adenocarcinoma is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.\n4. Pancreatic adenocarcinoma has progressed on at least 1 prior systemic treatment regimen, or the patient refuses standard treatment.\n5. Prior pancreatic adenocarcinoma treatment was discontinued for at least 14 days prior to the Baseline Visit.\n6. Measurable or evaluable disease by RECIST v1.1.\n7. Patients with a history of treated central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: disease outside the CNS is present; there is no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study; and there is no history of intracranial hemorrhage or spinal cord hemorrhage.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2.\n9. The following laboratory values must be documented prior to the first dose of study drug:\n\n   * Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL\n   * Platelet count ≥50 × 109\u002FL\n   * Creatinine clearance ≥50 mL\u002Fmin (estimated glomerular filtration rate by the Cockcroft-Gault) or serum creatinine ≤2.0 mg\u002FdL\n   * Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤10X the upper limit of normal\n   * Total bilirubin ≤10 mg\u002FdL\n   * Serum albumin ≥2.0 g\u002FdL.\n10. Life expectancy of ≥8 weeks.\n11. For women of childbearing potential, negative serum pregnancy test result.\n12. Provide written informed consent to participate.\n13. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures\n\nExclusion Criteria:\n\n1. Receipt of systemic cancer therapy within 14 days prior to the Baseline Visit or concurrently during the trial.\n2. Persistent toxicity ≥Grade 2 from previous cancer therapy, with the exceptions of alopecia and Grade 3 peripheral neuropathy.\n3. Major surgery or radiation therapy within 14 days prior to the Baseline Visit.\n4. Use of any investigational agent within the shorter of 4 weeks or 5 half-lives prior to the Baseline Visit.\n5. Concomitant use of P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) inhibitors and\u002For substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product.\n6. Unable to swallow orally administered medication or presence of a gastrointestinal disorder likely to interfere with absorption of the study medication.\n7. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.\n8. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.\n9. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or other immunodeficiency.\n10. Active second primary malignancy (other than pancreatic adenocarcinoma) requiring treatment.\n11. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).\n12. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 1 month prior to initiation of study drug.\n13. History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the corrected QT interval (QTc) (Fridericia) interval to \\>470 msec \\[mean of triplicate electrocardiogram measurements\\] (patients with bundle branch block or a cardiac pacemaker will not be excluded for QTc reasons).\n14. Pregnant or lactating female.\n15. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug and for at least 1 month thereafter.\n16. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 1 month afterward.\n17. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and\u002For with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.",{"count":105,"type":18},20,[21],"This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients.",[109,110],"Pancreatic Adenocarcinoma","Pancreatic Cancer","2025-01-29",{"date":113,"type":33},"2025-01-31",{"date":115,"type":33},"2024-11-10",{"date":117,"type":18},"2026-12-15",{"name":39,"class":40},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":19,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100416065","phase-2-namodenoson-in-the-treatment-of-non-alcoholic-steatohepatitis-nash-100416065","NCT04697810","Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. AST at Screening of ≥20 IU\u002FL.\n3. FibroScan LSM ≥8.5 kPa\n4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.\n5. Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).\n6. At least 2 of the following criteria for the metabolic syndrome:\n\n   * Obesity, defined waist circumference \\>88 cm for women or \\>102 cm for men\n   * Hypertriglyceridemia, defined as \\>150 mg\u002FdL (\\>1.7 mmol\u002FL) or on drug treatment for hypertriglyceridemia\n   * Reduced high-density lipoprotein (HDL) cholesterol, defined as \\\u003C40 mg\u002FdL (\\\u003C1.03 mmol\u002FL) in men or \\\u003C50 mg\u002FdL (\\\u003C1.3 mmol\u002FL) in women\n   * History of hypertension, currently controlled in the judgment of the Investigator\n   * Elevated fasting glucose, defined as ≥100 mg\u002FdL (≥5.6 mmol\u002FL).\n7. Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:\n\n   * Serum albumin ≥3.5 gm\u002FdL\n   * International normalized ratio ≤1.3\n   * Serum total bilirubin ≤2.0 mg\u002FdL (unless subject has known Gilbert's Syndrome).\n8. The following laboratory values must be documented at Screening:\n\n   * Absolute neutrophil count at least 1.0 x 109\u002FL\n   * Platelet count at least 150 x 109\u002FL\n   * Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2\n9. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range.\n10. Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after.\n11. Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.\n12. Understand and provide written informed consent to participate.\n13. Willing to undergo 2 liver biopsies.\n14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.\n2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.\n3. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.\n4. Weight loss of \\>5% within 3 months prior to Baseline.\n5. History of bariatric surgery within 5 years of Screening.\n6. Diabetes mellitus other than Type II.\n7. Hemoglobin A1c \\>9.0% (subjects with diabetes).\n8. Any contraindication to percutaneous liver biopsy.\n9. Daily alcohol intake \\>20 g (2 units)\u002Fday for women and 30 g (3 units)\u002Fday for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.\n10. Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia \\[sitagliptin\\], Byetta \\[incretin\\], etc.), pioglitazone, or SGLT2 inhibitors (\"gliflozin\" drugs); unless the dose and regimen has been stable for at least 3 months.\n11. Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.\n12. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \\>10 mg prednisone-equivalent concurrently or within 1 year.\n13. More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.\n14. Uncontrolled or clinically unstable thyroid disease.\n15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.\n16. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.\n17. QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \\> 450 milliseconds (msec) for males or \\> 470 msec for females.\n18. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.\n19. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.\n20. Active gastrointestinal disease which could interfere with the absorption of oral medication.\n21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.",{"count":127,"type":18},114,[21],"Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.",[131],"NASH - Nonalcoholic Steatohepatitis","2024-07-30",{"date":134,"type":33},"2024-07-31",{"date":136,"type":33},"2021-12-10",{"date":138,"type":18},"2025-10-15",{"name":39,"class":40},24,""]