[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rockefeller University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100505095","phase-1-hepb-mab19-in-individuals-with-chronic-hepatitis-b-infection-100505095",false,"NCT05856890","HepB mAb19 in Individuals With Chronic Hepatitis B Infection","A Phase 1, Placebo-controlled, Dose-escalation Study of the Safety, Pharmacokinetics, and Antiviral Activity of a Potent Neutralizing Monoclonal Antibody in Individuals With Chronic Hepatitis B Infection","Inclusion Criteria:\n\n* Age 18 to 70;\n* HBV infection confirmed by positive HBsAg for \\>\u002F= 6 months;\n* On HBV-active nucleos(t)ide therapy for \\>\u002F= 6 months without change in NRTI in the previous 3 months;\n* The following laboratory values within 49 days from study entry (day 0):\n* HBV DNA below lower limit of quantification;\n* HBsAg \\> 10 IU\u002FmL;\n* HBs antibody negative;\n* Ability and willingness to provide informed consent;\n* For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and\u002For bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry).\n* Participants who can become pregnant must agree to use two methods of contraception.\n* Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of medical records or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.\n* Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.\n\nExclusion Criteria:\n\n\\- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\\\u003C 9 kpa) within 12 months from entry or done at the pre-infusion visit.\n\nNote: If FibroScan results from within 12 months are not available, imaging will be performed at the pre-infusion visit.\n\n* Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.\n* Alpha fetoprotein \\> 20 ng\u002Fml Note: AFP above normal but \\\u003C 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).\n* HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.\n* History of hematopoietic stem cell transplant or solid organ transplant;\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable);\n* History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death);\n* History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor \\[QTcF\\] \\> 450 ms for males and QTcF \\> 470 ms for females);\n* History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months;\n* History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.\n* Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0.\n* Laboratory abnormalities in the parameters listed below:\n* Absolute neutrophil count \\\u003C 1,000 \u002Fmm3\n* Hemoglobin \\\u003C 10 gm\u002FdL\n* Platelet count \\\u003C 150,000 \u002Fmm3\n* ALT \\> 2.0 x ULN\n* AST \\> 2.0 x ULN\n* Total bilirubin \\> 1.5 ULN (except individuals with known Gilbert's)\n* Albumin \\\u003C 3.5 gm\u002FdL\n* Calculated creatinine clearance \\\u003C 70 mL\u002Fmin (using the Cockcroft Gault formula).\n* INR \\>\u002F= 1.2\n* Pregnancy or lactation;\n* Any vaccination within 14 days prior to IP administration;\n* Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);\n* Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.","ALL","18 Years","70 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).",[27,28],"Hepatitis b Virus","Hepatitis B",[30,31,32],"monoclonal antibody","HBV","HepB mAb19","RECRUITING","2026-01-29",{"date":36,"type":37},"2026-02-02","ACTUAL",{"date":39,"type":37},"2023-08-07",{"date":41,"type":21},"2028-03-30",{"name":43,"class":44},"Rockefeller University","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100493771","early-phase-1-predictors-of-aspirin-failure-in-preeclampsia-prevention-100493771","NCT05709483","Predictors of Aspirin Failure in Preeclampsia Prevention","Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol","Inclusion Criteria:\n\n1. Women aged 18-45 years with prior history of preeclampsia who received low dose aspirin in their subsequent gestation and either did or did not have a recurrence of preeclampsia.\n2. Aspirin was given in their subsequent pregnancy in a 81 mg dose prior to 16 weeks of gestation, and was taken with a self-reported compliance rate of at least 80%\n3. Subsequent pregnancy lasted beyond 20 weeks of gestation\n4. Willingness to abstain from non-prescription non-steroidal anti-inflammatory drugs (NSAIDs), which are known to interfere with platelet function assays, for one week prior to platelet function analyses.\n5. Healthy controls recruited for SNP assay optimization:\n\nWomen aged 18 years or older, with no other specific inclusion criteria that need to be met in order to be enrolled for the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years or \\>45 years\n2. Any clinically significant adverse reaction to aspirin on prior exposure\n3. Known bleeding disorder based on personal or family history\n4. History of kidney or liver impairment\n5. Current pregnancy\n6. Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants).\n7. Chronic hypertension (systolic blood pressure \\>140 mmHG or diastolic pressure \\>90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician)\n8. Diabetes mellitus\n9. Current known malignancy\n10. History of hemorrhagic stroke\n11. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons\n12. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.\n13. Healthy controls:\n\nA. \\\u003C18 years of age. B. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons C. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.",true,"FEMALE","45 Years",{"count":57,"type":21},130,[59],"EARLY_PHASE1","Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.",[62],"Preeclampsia","2025-10-28",{"date":65,"type":37},"2025-10-30",{"date":67,"type":37},"2023-04-13",{"date":69,"type":21},"2026-11-01",{"name":43,"class":44},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":53,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":71},"100074964","the-genetics-and-functional-basis-of-inherited-platelet-white-blood-cell-red-blood-cell-and-blood-clotting-disorders-100074964","NCT00230165","The Genetics and Functional Basis of Inherited Platelet, White Blood Cell, Red Blood Cell, and Blood Clotting Disorders.","Studies of Interactions Among Normal and Abnormal Blood Cells, and the Vessel Wall, and Studies of Genetic and Functional Basis of Inherited Platelet, White Blood Cell, Red Blood Cell and Coagulation Disorders","Inclusion Criteria:\n\nA. Normal Healthy Volunteers:\n\n1. Normal healthy volunteers\n2. 18 years of age or older\n3. Either sex\n4. Any ethnic background.\n\nB. Patients with Glanzmann thrombasthenia or their relatives, inherited qualitative and\u002For quantitative platelet disorders, inherited disorders of white blood cells, inherited disorders of coagulation (including von Willebrand disease):\n\n1. Adults and children\n2. Either sex\n3. Any ethnic background\n\nExclusion Criteria:\n\nA. Normal Healthy Volunteers:\n\n1. For studies of platelets that may be affected by anti-platelet therapy, ingestion of aspirin or similar medication in the past week.\n2. Having given blood in the last 8 weeks such that the current donation would exceed a total of 250 ml for the 8 week period.\n3. Having given blood in the past week such that this donation would result in more than 2 donations in one week.\n\nB. Patients with Glanzmann thrombasthenia or their relatives, inherited qualitative and\u002For quantitative platelet disorders, inherited disorders of white blood cells, inherited disorders of coagulation (including von Willebrand disease).\n\n1. For studies of platelets that may be affected by antiplatelet therapy, ingestion of aspirin or similar medication in the past week\n2. If the patient is known to have a hematocrit ≥25 (assay performed in past 3 months), the same blood drawing criteria as in A, with the addition that for children less than 18 years of age, the maximum amount of blood allowed to be donated in an 8 week period is the lesser of 50 ml or 3 ml\u002Fkg.\n3. If the patient has a hematocrit \\\u003C25 or if the hematocrit is unknown, the blood drawing limit is the lesser of 20 ml or 1 ml\u002Fkg in any 8 week period.",{"count":80,"type":21},60,"OBSERVATIONAL","Blood contains red blood cells, white blood cells, and platelets, as well as a fluid portion termed plasma. We primarily study blood platelets, but sometimes we also analyze the blood of patients with red blood cell disorders (such as sickle cell disease), white blood cell disorders, and disorders of the blood clotting factors found in plasma.\n\nBlood platelets are small cell fragments that help people stop bleeding after blood vessels are damaged. Some individuals have abnormalities in their blood platelets that result in them not functioning properly. One such disorder is Glanzmann thrombasthenia. Most such patients have a bleeding disorder characterized by nosebleeds, gum bleeding, easy bruising (black and blue marks), heavy menstrual periods in women, and excessive bleeding after surgery or trauma. Our laboratory performs advanced tests of platelet function and platelet biochemistry. If we find evidence that a genetic disorder may be responsible, we analyze the genetic material (DNA and RNA) from the volunteer, and when possible, close family members to identify the precise defect.",[84],"Glanzmann Thrombasthenia",[86,87,88,89,90],"Platelets","Erythrocytes","Leukocytes","Coagulation","Thrombosis","2025-10-15",{"date":93,"type":37},"2025-10-20",{"date":95,"type":4},"2005-09",{"date":97,"type":21},"2030-06",{"name":43,"class":44},""]