[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Protara Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,78,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100629875","phase-3-efficacy-and-safety-of-intravesical-tara-002-compared-with-investigators-choice-of-intravesical-chemotherapy-in-participants-with-bcg-nave-high-grade-non-muscle-invasive-bladder-cancer-100629875",false,"NCT07480356","Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-3","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor.","ALL","18 Years",{"count":20,"type":21},284,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.\n\nThe main questions it aims to answer are:\n\n* Can the study drug help participants with this type of cancer?\n* Is the study drug safe?\n* What are the side effects of the study drug?\n\nResearchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.",[27,28,29],"Bladder (Urothelial, Transitional Cell) Cancer","Non-Muscle Invasive Bladder Carcinoma","Non-muscle Invasive Bladder Cancer With Carcinoma in Situ",[31,32,33,34],"BCG-naive","Non-muscle invasive bladder Cancer","bladder cancer","carcinoma in situ","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-05-29",{"date":43,"type":21},"2032-11",{"name":45,"class":46},"Protara Therapeutics","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100586097","phase-2-study-of-choline-chloride-for-injection-in-adolescent-and-adult-patients-with-intestinal-failure-receiving-long-term-parenteral-support-100586097","NCT06910943","Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support","A Phase 2b\u002F3 Randomized Open-Label Dose-Selection Study With Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults With Intestinal Failure Receiving Long-Term Parenteral Support","THRIVE-3","Key Inclusion Criteria:\n\n* Male or female 12 years of age or older at the time of signing the informed consent\n* Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry\n* Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week\n* Females of childbearing potential must have a negative urine pregnancy test at screening\n\nKey Exclusion Criteria:\n\n* Patients taking steatogenic medications for ≥ 12 weeks in the past 12 months; those taking any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry\n* Evidence of systemic active infection at the time of dosing\n* Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study\n* Participants unwilling to limit alcohol intake to no more than 20\u002Fg a day for 24 hours prior to their screening visit and for the duration of the study\n* Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)\n* Clinically significant renal disease\n* Low B12 or low serum folic acid levels that are less than the normal range\n* Fulminant liver failure, with active bleeding and\u002For encephalopathy","12 Years",{"count":58,"type":21},129,[60,24],"PHASE2","TARA-001-301 is a Phase 2b\u002F3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of Choline Chloride for Injection (Low Dose and High Dose) versus Placebo in adolescents (ages 12 to \\\u003C 18 years of age) and adults (≥ 18 years of age) with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated.\n\nParticipants will be enrolled in one of 2 parts, each part will be followed by an open-label extension period of approximately a year.\n\nPart 1: Open-Label Dose-Selection Phase Part 2: Double-Blind, Placebo-Controlled Phase\n\nThe purpose of the Open-Label Dose-Selection Phase is to evaluate the safety, tolerability, how Choline Chloride for Injection (study drug) is distributed in the body, and to select 2 of 3 doses for testing in the Double-Blind, Placebo-Controlled Phase.\n\nThe purpose of the Double-Blind, Placebo-Controlled Phase is to assess the safety of the study drug and how well the study drug works at the 2 selected dose levels.",[63,64],"Choline Deficiency","Liver Injury",[66,67,68,69,70],"Intestinal Failure","Parenteral Nutrition","Parenteral Support","Choline Chloride","choline deficiency",{"date":38,"type":39},{"date":73,"type":39},"2025-12-10",{"date":75,"type":21},"2028-06",{"name":45,"class":46},17,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100512340","phase-2-safety-and-efficacy-study-of-intravesical-instillation-of-tara-002-in-adults-with-high-grade-non-muscle-invasive-bladder-cancer-100512340","NCT05951179","Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer","A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-2","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta\u002FT1) who are BCG unresponsive.\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor",{"count":87,"type":21},131,[60],"TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta\u002FT1).\n\nThe purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).\n\nThis Phase 2 study includes participants with CIS NMIBC (± Ta\u002FT1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.\n\nParticipants will be enrolled into one of 2 cohorts:\n\nCohort A:\n\n* Participants with CIS (± Ta\u002FT1) who are BCG naive, or\n* Participants with CIS (± Ta\u002FT1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis\n\nCohort B:\n\n* Participants who are BCG unresponsive",[91],"Non-muscle Invasive Bladder Cancer",[32,33,93,94,34],"high grade Ta","high grade NMIBC",{"date":96,"type":39},"2026-06-30",{"date":98,"type":39},"2023-09-15",{"date":100,"type":21},"2032-03",{"name":45,"class":46},71,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":18,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100506252","phase-2-safety-and-efficacy-study-of-intracystic-tara-002-for-the-treatment-of-lymphatic-malformations-in-participants-6-months-to-less-than-18-years-of-age-100506252","NCT05871970","Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age","A Phase 2a\u002Fb Single Arm Open Label Study to Evaluate the Safety and Efficacy of Intracystic Administration of TARA-002 in Participants Between 6 Months to Less Than 18 Years of Age for the Treatment of Macrocystic and Mixed Cystic Lymphatic Malformations","STARBORN-1","Inclusion Criteria:\n\n* Male or female participants 6 months to less than 18 years of age at the time of informed consent\u002Fassent form was signed\n* Participants whose parent\u002FLAR(s) have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them\n* Participants with macrocystic LM or mixed cystic LM (≥ 50% macrocystic disease measured by volume) of the Head\u002FNeck\u002FMediastinum according to the ISSVA 2018 criteria (ISSVA 2018) measured via LM imaging at Screening to confirm, upon central review, the diagnosis of macrocystic or mixed cystic LM\n* Participants who may have had surgical or sclerotherapy treatment for their LM, but not within six months of the consent\u002Fassent form being signed\n\nExclusion Criteria:\n\n* Penicillin allergy\n* Vascular tumors or combined vascular malformations\n* Microcystic LM or mixed cystic LM with predominant microcystic features\n* LMs of the orbit (orbital LM) as target cyst\n\nFor more information on eligibility criteria, please contact the sponsor.","6 Months",{"count":113,"type":21},38,[60],"This is a Phase 2a\u002Fb single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.",[117],"Lymphatic Malformation",[119,120],"Macrocystic lymphatic malformations","Mixed-cystic lymphatic malformations","2026-05-14",{"date":123,"type":39},"2026-05-18",{"date":125,"type":39},"2023-10-18",{"date":127,"type":21},"2027-05",{"name":45,"class":46},10,""]