[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chagas-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chagas-disease":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,37,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100475978","an-observational-pregnancy-safety-study-in-women-who-were-exposed-to-the-drug-nifurtimox-during-pregnancy-to-learn-about-the-risk-of-pregnancy-complications-and-about-the-mothers-and-babys-health-100475978",false,"NCT05477953","An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant","Inclusion Criteria:\n\n* Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period \u002F time of conception to pregnancy outcome).\n* Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":18,"type":19},50,"ESTIMATED","OBSERVATIONAL","This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.\n\nChagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.\n\nNifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.\n\nIt is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.\n\nIn this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:\n\n* Birth defects (abnormal and problematic structures or functions, a child is born with)\n* Pregnancy outcomes (like live birth, preterm birth, still birth\u002Fdeath of the unborn baby, miscarriage, or abortion)\n* Certain health problems of the child up to 12 months of age\n* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.\n\nThe study will run for approximately 10 years.",[23],"Chagas Disease","NOT_YET_RECRUITING","2026-06-12",{"date":27,"type":28},"2026-06-15","ACTUAL",{"date":30,"type":19},"2026-12-31",{"date":32,"type":19},"2032-01-31",{"name":34,"class":35},"Bayer","INDUSTRY",12,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100564701","phase-2-a-study-of-efficacy-safety-tolerability-of-lxe408-in-participants-with-chronic-chagas-disease-100564701","NCT06632600","A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.","A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.","Inclusion Criteria:\n\n* Male or female participants aged ≥ 18 years to ≤ 60 years old\n* Confirmed diagnosis of T. cruzi infection\n* History that participant has been determined to be in chronic phase of CD\n* Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study\n* Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole\n* Ability and willingness to communicate well with the investigator\u002Fstudy site and comply with requirements of the study\n\nExclusion Criteria:\n\n* Signs (on physical examination) and\u002For symptoms of CD in the acute phase as determined by the investigator at screening\n* History of CD treatment with benznidazole or nifurtimox at any time in the past\n* History of and\u002For current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease\n* Participants who weigh \\\u003C 50 kg or \\>90kg at screening\n* At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging\n* Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease\u002Fcondition exacerbated during the study, or would compromise participant compliance or preclude completion of the study\n* Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III\u002FIV heart failure (due to Chagas disease or other conditions); arrhythmias\n* Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, or endemic mycoses, and\u002For documented positivity for human immunodeficiency virus (HIV) infection.\n\n  * Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening\n* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period\n\n  * Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded\n  * Liver disease or liver injury as indicated by abnormal liver function tests (LFTs):\n\nAny single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome\n\n* History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated eGFR \\\u003C60 mL\u002Fmin (\\\u003C0.835 mL\u002Fs) using the CKD-EPI formula for adults\n\n  * Participants with screening hematology parameters outside of the thresholds\n  * Current use of medications prohibited by the protocol at screening and\u002For baseline visits, or expected use of any prohibited medication during the study treatment period\n* Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.\n\n  * Use of other investigational drugs at the time of study drug dosing\n  * History of multiple and recurring allergies or allergy to the investigational compound\u002Fcompound class being used in this study or to benznidazole\n  * History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing\n  * Pregnant or nursing (lactating\u002Fbreast-feeding) women\n  * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of investigational drug and benznidazole\n  * Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","60 Years",{"count":48,"type":19},130,"INTERVENTIONAL",[51],"PHASE2","This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.",[23],[55,56,57,58,59,60,61],"LXE408","Chronic Chagas disease","Chronic indeterminate Chagas disease","Chronic Chagas disease without severe organ dysfunction","CICD","Chronic CD","Trypanosoma cruzi","RECRUITING","2026-05-29",{"date":65,"type":28},"2026-06-01",{"date":67,"type":28},"2025-04-28",{"date":69,"type":19},"2030-09-21",{"name":71,"class":35},"Novartis Pharmaceuticals",20,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":81,"targetDuration":4,"studyType":49,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100431394","phase-3-shorter-benznidazole-regimens-compared-to-the-standard-regimen-for-chagas-disease-100431394","NCT04897516","Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease","Phase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease","NuestroBen","Inclusion criteria (Subjects must meet ALL the inclusion requirements listed below to enter the study):\n\n* Signed informed consent form;\n* Between ≥18 and ≤60 years of age;\n* Weight ≥ 50 kg to ≤ 95 kg;\n* Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two tests must be reactive);\n* Serial qualitative PCR (one blood sample divided in three DNA extractions, at least one of which must be positive);\n* Women of childbearing potential must have a negative pregnancy result at the time of inclusion, must not be breast-feeding, and must use a highly effective method of contraception during study treatment and until 30 days after the last dose of study treatment or demonstrate permanent sterilization;\n* Ability to comply with all exams and specific protocol visits;\n* Having a permanent address;\n* ECG criteria: (Heart rate: 50 -100 bpm or isolate sinus bradycardia from 41 to 59 beats\u002Fmin; QRS ≤120 msec, and QTc ≥ 350 msec and ≤ 450 msec) at screening) or following findings belonging to non-severe chagasic cardiomyopathy: uncomplete right bundle branch block, Left anterior fascicular block, First-degree atrioventricular block, Low voltage. The abnormalities included are not exclusionary;\n* Normal or minimal structural changes in echocardiogram (left ventricular diastolic diameter (LVDD) \\\u003C= 55 mm, diastolic dysfunction, absence of Microaneurysm or tip aneurysm, absence of hypo or generalized akinesia, absence of Systolic dysfunction (low fractional shortening and ejection fraction), and\u002For absence of mural thrombus);\n* Not presenting signs or symptoms of moderate- severe chronic cardiac and\u002For digestive forms of Chagas disease (criteria detailed in Study Manual and specific SOP);\n* No prior history of mental disorders or suicidal tendencies;\n* Not suffering from known acute or chronic illnesses at the moment of selection for the study that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infections, immunosuppressive conditions, or liver or kidney diseases that have required treatment);\n* Not having received a formal indication not to take BZN (contraindication, according to the Summary of Product Characteristics - SmPC);\n* No prior history of hypersensitivity, allergy, or serious adverse reactions to any of the nitroimidazole compounds (including BNZ) and\u002For its components\u002Fexcipients;\n* Have not previously undergone antiparasitic treatment for T. cruzi infection;\n* No prior history of drug abuse or alcoholism;\n* Not suffering from any disease or condition that prevents subjects from consuming oral medication.\n\nExclusion criteria (The presence of any of the items below will exclude subjects from inclusion in the study):\n\n* Subject pregnant or intending to become pregnant during treatment and within 30 days of the last dose of study treatment;\n* Signs or symptoms of the established (moderate- severe) chronic cardiac and\u002For digestive form of Chagas disease, or any ECG\u002F echocardiographic findings not included at Inclusion criteria;\n* History of cardiomyopathy, heart failure, or severe ventricular arrhythmia;\n* History of digestive surgery potentially related to Chagas Disease or megacolon \u002F mega-esophagus;\n* Acute or chronic disease that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infection, history of immunosuppressive conditions, or liver or kidney disease that has required treatment);\n* Laboratory test values that are considered clinically significant or outside the allowable values, per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1;\n* Disease or clinical condition that prevents subjects from consuming oral medication;\n* Subjects with a contraindication (known hypersensitivity) to any of the nitroimidazole compounds, e.g. metronidazole;\n* Subjects with a history of allergy (serious or not), allergic rash, asthma, intolerance, sensitivity or photosensitivity;\n* Concomitant use and\u002For consumption of allopurinol, antimicrobial and antiparasitic agents, herbal medicines, dietary supplements and energy drinks;\n* Scheduled surgery that may interfere with the conduct of the trial and\u002For with the treatment evaluation;\n* Inability to attend study visits, comply with treatment, and cooperate with study procedures;\n* Previous participation in a trial for the evaluation of the treatment of T. cruzi infection;\n* Simultaneous participation in another trial or within 3 months prior to screening for this trial (in accordance with national regulations).\n* Subjects suffering from a serious medical or psychiatric illness that increases the risk associated with study participation or that interferes with the interpretation of study results should not be included.",{"count":82,"type":19},300,[84],"PHASE3","Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.",[23],[88,89,90,91,92],"Chagas disease","Benznidazole","Trypanosoma Cruzi","Standar treatment","Short treatment","2023-11-27",{"date":95,"type":28},"2023-11-30",{"date":97,"type":28},"2021-07-28",{"date":99,"type":19},"2026-12-01",{"name":101,"class":35},"Laboratorio Elea Phoenix S.A.",6]