[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Resverlogix Corp\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100561450","phase-2-a-study-of-apabetalone-in-subjects-with-long--covid-100561450",false,"NCT06590324","A Study of Apabetalone in Subjects With Long -COVID","A Phase II, Multi-centre Open Label Study to Assess the Efficacy and Safety of Oral Apabetalone With Background Dapagliflozin in Subjects With Long -COVID-19 (Post-COVID-19 Conditions) and Type 2 Diabetes Mellitus (T2DM)","Inclusion Criteria:\n\n1. Able and willing to provide written (signed and dated) informed consent before participation in the study, and to comply with scheduled visits, treatment plan, and other study-related procedures to complete the study.\n2. Male or female subjects who are ≥ 18 years of age at Screening.\n3. Documented diagnosis of T2DM (one or more of the following criteria must be met):\n\n   1. Documented history of T2DM\n   2. History of taking diabetes medication\n   3. HbA1c ≥6.5% at Screening\n4. Must be taking dapagliflozin as part of their diabetes medication, or, based on the Principal Investigator's judgment and indication, be willing to commence sponsor-provided dapagliflozin 10 mg daily for the duration of the study.\n5. History of Long-COVID symptoms within 3 months from the onset of COVID-19 that have lasted for at least 2 months. Symptoms are listed in Long Covid Symptom Tool (LCST).\n6. A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1)\n7. A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1)\n8. Female subjects of childbearing potential and nonsterile male subjects with female partners of childbearing potential must agree to either remain abstinent or use highly effective non-hormonal methods of contraception throughout the study and at least 30 days after the last dose of study drug has been taken. Subjects must adhere to contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n\n   \\-\n\n   Exclusion Criteria:\n9. Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \\\u003C25 mL\u002Fmin\u002F1.73 m2\n10. New York Heart Association Class IV congestive heart failure\n11. Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure; chronic liver diseases such as primary biliary cholangitis, untreated hemochromatosis, and primary sclerosing cholangitis\n12. Subject meets any of the following laboratory criteria at Screening:\n\n    * Alanine transaminase (ALT) or aspartate transaminase (AST) values \\> 1.5x the upper limit of normal (ULN)\n    * Total bilirubin \\>1.5 × ULN.\n    * Evidence of an active hepatitis B virus or hepatitis C virus infection\n    * History of a positive test for human immunodeficiency virus (HIV)\n13. Subjects taking concomitant cytochrome P450 3A4 strong inducers and\u002For strong inhibitors, or corticosteroid use \\>10 mg daily prednisone or equivalent.\n14. Subjects who have received a COVID-19 vaccine or booster in the last 30 days prior to screening (Visit 1).\n15. Subject who have participated in a clinical study and received any investigational medication within the last 30 days prior to screening (Visit 1).\n16. Female subjects who are pregnant, planning to get pregnant, lactating\u002Fbreastfeeding, or has a positive urine pregnancy test at the Screening Visit or prior to enrollment at the Day 1 visit.\n17. Subjects whose safety may be compromised by study participation or are not, in the opinion of the investigator, able or willing to comply with the protocol.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.",[27],"Post-Acute COVID-19 Syndrome","RECRUITING","2025-04-15",{"date":31,"type":32},"2025-04-18","ACTUAL",{"date":29,"type":32},{"date":35,"type":20},"2026-03-30",{"name":37,"class":38},"Resverlogix Corp","INDUSTRY",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100298085","phase-1-a-two-part-phase-2a-study-of-rvx000222-in-patients-with-end-stage-renal-disease-treated-with-hemodialysis-100298085","NCT03160430","A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis","A Two-Part Phase 2a Study in Patients With End-Stage Renal Disease Treated With Hemodialysis; Part A is an Open-Label Study Arm to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of 100 mg RVX000222; and Part B is a Double-Blind, Randomized, Placebo-Controlled, Sequential Cross-Over Study Arm to Evaluate the Efficacy, Safety, and Pharmacokinetics of RVX000222","Inclusion Criteria:\n\n1. Men or women ≥18 and ≤80 years of age.\n2. Diagnosis of end-stage renal disease and receiving hemodialysis an average of three (3) times per week for at least ninety (90) days prior to Enrollment\u002FVisit 2.\n3. Clinically stable, in the judgment of the investigator.\n4. Female subjects must meet one of the following:\n\n   1. If of childbearing potential, must have a negative serum pregnancy test and be willing and able to use medically acceptable non-hormonal method of birth control (non-hormonal intrauterine device, condom, or diaphragm) or remain abstinent from Screen until Follow-up Visit, or\n   2. Be of non-child-bearing potential: post-surgical sterilization (hysterectomy or a bilateral oophorectomy) or post-menopausal. Post-menopausal is defined as amenorrhea for ≥2 years at Screen\u002FVisit 1.\n5. In the view of the investigator, during the course of the trial, subject is expected to:\n\n   1. remain on unchanged standard of care medication from 4 weeks prior to Enrollment\u002FVisit 2.\n   2. not require hospitalization for any condition other than routine hemodialysis.\n6. Have given signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Planned major surgery in the next 4 months, including renal transplant, from Enrollment\u002FVisit 2.\n2. Major surgery, in the judgement of the investigator, within 12 weeks before enrollment\u002FVisit 2 (excluding vascular access surgery).\n3. Hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack or peripheral arterial disease within 6 months before Enrollment\u002FVisit 2.\n4. New York Heart Association (NYHA) Classification, Class III or IV Heart Failure at Screen\u002FVisit 1.\n5. Diastolic blood pressure \\>110 mm Hg or systolic blood pressure \\>180 mm Hg during screen.\n6. Currently receiving antibiotic therapy for systemic infection.\n7. In the judgement of the Investigator, evidence of active hepatitis. Hepatitis serology testing will be performed at Screen\u002FVisit 1.\n8. History of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.\n9. Red blood cell (RBC) transfusions within 12 weeks before Enrollment\u002FVisit 2.\n10. Current or recent (within 12 months prior to Visit 1) treatment with immunosuppressants (e.g., cyclosporine).\n11. Use of fibrates at any dose or niacin\u002Fnicotinic acid 250 mg or more within 30 days prior to Screen\u002FVisit 1.\n12. Diagnosis of systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).\n13. Hemoglobin \\\u003C9.5 g\u002FdL at Screen\u002FVisit 1.\n14. Alanine aminotransferase (ALT) \\>1.5 x upper limit of normal (ULN) at Screen\u002FVisit 1.\n15. Bilirubin \\>1.0 x ULN at Screen\u002FVisit 1.\n16. Pregnant or breast-feeding women.\n17. Any condition which, in the opinion of the investigator, may place the subject at higher risk from his\u002Fher participation in the study, or is likely to prevent the subject from complying with the requirements of the study or completing the study.\n18. Treatment with an investigational agent or device within 30 days or 5 half-lives before Enrollment\u002FVisit 2 or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study.\n19. History of noncompliance with medical regimens or unwillingness to comply with the study protocol.\n20. In the judgement of the Investigator, any disorder that may impact the ability to give informed consent for participation in this study.\n21. Any condition that, in the opinion of the investigator, would confound the evaluation and interpretation of efficacy and\u002For safety data.\n22. Persons directly involved in the execution of this protocol.\n\n    Exclusion Criteria, Part A Only:\n23. Are unwilling to abstain from alcoholic beverages, caffeine or xanthine-containing products (e.g., tea, coffee, chocolate, cola), and use of nicotine products from 24 hours prior to Clinical Research Unit (CRU) admission to 48 hours post RVX000222 dose administration.\n\nExclusion Criteria, Part B Only:\n\n23\\. Parathyroid hormone, intact (PTH, intact) \\\u003C150 pg\u002FmL or \\>800 pg\u002FmL at Screen\u002FVisit 1.","80 Years",{"count":49,"type":20},44,[51,23],"PHASE1","This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care.\n\nPart B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC.\n\nThe primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.",[54],"Kidney Failure, Chronic",[56,57,58,59,60,61,62],"Chronic Kidney Failure","ESRD","End-Stage Kidney Disease","End-Stage Renal Disease","Renal Disease, End-Stage","Renal Failure, Chronic","Renal Failure, End-Stage","NOT_YET_RECRUITING","2023-11-14",{"date":66,"type":32},"2023-11-15",{"date":68,"type":20},"2024-11-22",{"date":70,"type":20},"2026-11-22",{"name":37,"class":38},""]