[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VIVUS LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100639334","phase-3-a-phase-3-study-of-extended-release-tacrolimus-in-subjects-with-pulmonary-arterial-hypertension-and-functional-limitations-100639334",false,"NCT07612657","A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations","A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications","TRANSCEND","Inclusion Criteria:\n\n* WHO Group 1 PH: Pulmonary Arterial Hypertension;\n* WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;\n* Right heart catheterization (RHC) at screening (or within 3 months prior to screening);\n* Screening 6MWD \\>75 meters to ≤450 meters.\n\nExclusion Criteria:\n\n* PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis\n* Chronic thromboembolic or portopulmonary hypertension\n* Total Lung Capacity (TLC) \\\u003C60% predicted;\n* FEV1\u002FFVC \\\u003C70% predicted or FEV1 \\\u003C60% predicted;\n* Evidence of left-sided heart disease;\n* Inability to safely attempt completion of the 6MWD;\n* Life expectancy \\\u003C6 months;\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI equation);\n* Moderate to severe hepatic dysfunction (Child-Pugh score \\>10);\n* Serum potassium \\>5.1 mEq\u002FL;\n* Use of experimental PAH treatments within the past 3 months;\n* Active infection requiring antibiotic, antifungal, or antiviral therapies;\n* Current systemic treatment with cyclosporine;\n* Known allergy or hypersensitivity to tacrolimus;\n* Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment","ALL","18 Years","75 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.",[28,29,30,31,32],"Pulmonary Arterial Hypertension","Pulmonary Arterial Hypertension (PAH)","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","Pulmonary Arterial Hypertension PAH","Pulmonary Arterial Hypertension WHO Group I",[34,28],"PAH","NOT_YET_RECRUITING","2026-05-22",{"date":38,"type":39},"2026-05-29","ACTUAL",{"date":38,"type":22},{"date":42,"type":22},"2029-11-30",{"name":44,"class":45},"VIVUS LLC","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100586428","phase-2-a-study-of-carmustine-with-and-without-ethanol-in-subjects-with-lymphoma-100586428","NCT06915246","A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma","A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;\n* Karnofsky performance status ≥ 70%;\n* Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;\n* Candidate for AHCT consolidation therapy as assessed by their treating physician;\n* Achieved a complete or partial response;\n* Completed collection of at least 2.0 x 10\\^6 CD34 cells\u002Fkg of autologous hematopoietic progenitor cells (HPCs) by apheresis;\n* Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;\n* Clinical laboratory and organ function criteria meeting study ranges\u002Flimits LVEF ≥ 50%; FEV1 \\> 65% of predicted measurement, DLCO ≥ 50% of predicted;\n* Seronegative for HIV Ag\u002FAb combo, HCV, active HBV, and syphilis\n\nExclusion Criteria:\n\n* Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;\n* Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;\n* Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;\n* Myelodysplasia or any active malignancy other than HL or NHL, or \\\u003C 5 years remission from any other prior malignancy;\n* Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;\n* Persistent marrow involvement (\\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;\n* Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;\n* Active hepatitis B or C viral infection or HBsAg positive;\n* Positive HIV antibody;",{"count":54,"type":22},49,[56],"PHASE2","A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.",[59,60,61],"Lymphoma","Non-Hodgkin Lymphoma","Hodgkin Lymphoma",[59,63,64,65],"AHCT","BiCNU","Carmustine","RECRUITING","2026-03-25",{"date":69,"type":39},"2026-03-27",{"date":71,"type":39},"2025-03-12",{"date":73,"type":22},"2027-04-30",{"name":44,"class":45},4,""]