[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610281":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":63,"collaborators":66,"id":70,"slug":45,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":45,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":45,"enrollmentInfo":78,"targetDuration":45,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo First","EXPERIMENTAL","Placebo for first 8 weeks, then washout for 4 weeks, and then 2-HOBA acetate for 8 weeks",[13,14],"Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate)","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"2-HOBA First","2-HOBA acetate for first 8 weeks, then washout for 4 weeks, and then placebo for 8 weeks",[13,14],[20,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","2-HOBA acetate (2-Hydroxybenzlamine acetate)","2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day",[16,9],[26,27,28,29],"2-hydroxybenzylamine","2-HOBA","salicylamine","IUPAC name: 2-(aminomethyl)phenol",{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","Placebo (provided as two capsules) three times per day",[16,9],[35],"indentical placebo",[37],{"name":38,"affiliation":5,"role":39},"Michelle J Ormseth, MD, MSCI","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Phicharmon Kulapatana (study coordinator)","CONTACT","615-936-5747",null,"phicharmon.kulapatana@vumc.org",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Nashville","Tennessee","37232","United States",{"type":55,"coordinates":56},"Point",[57,58],-86.78444,36.16589,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":44,"phoneExt":45,"email":46},"Phicharmon Kulapatana",{"type":39,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Michelle Ormseth","Associate Professor",[67],{"name":68,"class":69},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100610281",false,"NCT07225543","2-HOBA in Systemic Lupus Erythematosus","Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥18 years\n* Female (biological)\n* Meeting the 2019 European League Against Rheumatism\u002F American College of Rheumatology classification criteria for SLE32\n* No change in immunosuppressants ≥3 months\n* Stable prednisone (or equivalent) dose ≤ 20mg\u002F day for ≥ 1 month\n* Elevated blood pressure defined as \\>120 and \\\u003C or = 160 mmHg systolic or \\>80 and \\\u003C or = 110 mmHg diastolic blood pressure at screening visit\n* No change in anti-hypertensive dose ≥2 weeks\n* Willingness to stop NSAIDs for ≥2 weeks before and throughout the study\n* If of childbearing potential, willingness to use effective birth control throughout the study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Male (biological)\n* Active cancer except for non-melanoma skin cancer\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl\n* Active infection requiring medical intervention\n* Major surgery in ≤ 3 months\n* Aspirin allergy\n* Use of MAO-I\n* Estimated creatinine clearance \\\u003C30 ml\u002Fmin\n* Known atrial fibrillation\n* Severe comorbid condition","FEMALE","18 Years",{"count":79,"type":80},42,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","This is a phase II randomized, placebo-controlled, double-blind, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE. 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 500mg 2-HOBA three times a day for 8 weeks followed by a 4 week washout and then 8 weeks of the other agent.\n\nPrimary outcome measures include change in 24-hour blood pressure and NETosis. This study will provide mechanistic information on the role of IsoLGs in autoimmune disease-associated hypertension and immune activation.",[86],"Systemic Lupus Erthematosus (SLE)",[88,89,90,91,92,93,94,95],"systemic lupus erythematosus","SLE","lupus","oxidative stress","hypertension","blood pressure","NETosis","isolevuglandins","2026-05-18",{"date":98,"type":99},"2026-05-22","ACTUAL",{"date":101,"type":99},"2026-05-15",{"date":103,"type":80},"2030-07-31",{"name":5,"class":6},1]