[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crimean-congo-hemorrhagic-fever\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crimean-congo-hemorrhagic-fever":27},{"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":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100582209","phase-2-umit-2---adaptive-phase-iib-platform-trial-to-determine-the-efficacy-and-safety-of-therapeutics-for-cchf-100582209",false,"NCT06860334","UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF","UMIT-2: A Randomized, Multi-country, Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for Crimean-Congo Haemorrhagic Fever","UMIT-2","Inclusion Criteria:\n\n* Adult in-patients (≥18 years) at the time of screening.\n* Confirmed CCHF infection: Laboratory confirmed CCHF infection defined as positive polymerase chain reaction (PCR) test within 5 days prior to randomisation.\n* Ability to provide informed consent signed by study patient or legally acceptable representative (for illiterate individuals).\n* Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in Protocol section 5.4) from the first administration of trial treatment, throughout trial treatment and for the duration outlined.\n* Severity Grading System (SGS) for CCHF - Low\u002Fmoderate risk. (Appendix 15).\n* Less than or equal to 7 days from onset of CCHF symptoms.\n* Willingness to participate in the full protocol.\n* Requirement to be hospitalised for treatment.\n\nExclusion Criteria:\n\n* Severe renal impairment: Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2).\n* Pregnant or breast feeding.\n* Anticipated transfer to another hospital which is not a study site within 72 hours.\n* Known Allergy to any study medication.\n* Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.\n* Known hypersensitivity or allergy to any component of the investigational medicinal product (IMP) or its excipients or documented previous intolerance or significant adverse reaction to the active IMP.\n* Participation in another clinical trial involving an investigational medicinal product (CTIMP) within 30 days or five half-lives of the prior IMP (whichever is longer).\n* Any condition or circumstance which, in the opinion of the Investigator, would place the participant at undue risk, compromise safety, or interfere with trial participation or interpretation of results.\n* Severity Grading System (SGS) for CCHF - High risk (Appendix 15).\n* Patients taking the drugs listed below within 30 days or 5 times the half-life (whichever is longer) of enrolment:\n\n  * Pyrazinamide: Pyrazinamide administration with favipiravir examined possible renal urate transporter interactions. Pyrazinamide increased blood uric acid levels 2 to 9 mg\u002FdL over baseline. The addition of favipiravir increased blood uric acid levels 4 to 11 mg\u002FdL over baseline, indicating a moderate additive effect.\n  * Repaglinide: Favipiravir administration with repaglinide, an anti-diabetic agent that is extensively metabolized by CYP2C8 and CYP3A4, increased repaglinide plasma AUC 30 to 50% due to inhibition of CYP2C8.\n  * Theophylline: Theophylline administration with favipiravir increases plasma Cmax and AUC of favipiravir through xanthine oxidase (XO) interaction. The primary metabolite of theophylline is known to be metabolized by XO which is partially involved in metabolism of favipiravir.\n  * Famciclovir, Sulindac: Famciclovir and Sulindac are converted to active metabolite by Aldehyde Oxidase (AO). Favipiravir inhibits AO and decrease the concentration of active metabolite of Famciclovir and Sulindac.","ALL","18 Years",{"count":20,"type":21},378,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","CCHF has a wide geographical distribution with cases mainly occurring in Asia, the Middle East, South-Eastern Europe and Africa. Since its emergence in 2002, Turkiye has been the epicentre of activity worldwide reporting up to more than 1000 cases annually. CCHF case management relies on the provision of optimised supportive care; therapeutic options lack a robust evidence base\n\nThe UMIT-2 Trial (UMIT = 'Hope' in Turkish) will be the first large randomised controlled trial of novel therapeutics in CCHF, undertaken in multiple trial sites in Turkiye and Iraq. It uses an efficient adaptive platform design (Phase IIb), focussed on antiviral efficacy with interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety",[27],"Crimean-Congo Hemorrhagic Fever",[29,30,31,32],"CCHF","Favipiravir","Ribavirin","Crimean Congo Hemorrhagic Fever","RECRUITING","2026-08-04",{"date":36,"type":37},"2026-08-07","ACTUAL",{"date":39,"type":37},"2026-06-04",{"date":41,"type":21},"2028-08-31",{"name":43,"class":44},"Liverpool School of Tropical Medicine","OTHER",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100577493","phase-1-safety-and-immunogenicity-of-a-self-amplifying-rna-vaccine-against-crimean-congo-hemorrhagic-fever-100577493","NCT06799013","Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever","A Phase 1, Open Label, Dose-Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of a Nanoparticle Carrier-Formulated Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever (HDT-321) in Healthy Adults","Inclusion Criteria:\n\n1. Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF.\n2. Body mass index (BMI) 17 to 35 inclusive at screening.\n3. Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign measurements\\*, and clinical laboratory assessments conducted no more than 30 days prior to the first study injection administration.\n4. Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the toxicity grading scale.\n5. Negative human immunodeficiency virus (HIV) 1\u002F2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.\n6. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception3 for at least 30 days prior to the first injection and for 60 days after the last injection. Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of and prior to each study injection.\n7. Able to understand and comply with planned study procedures and willing to be available for all study required procedures, visits, and telephone calls for the duration of the study.\n8. Provide written informed consent before initiation of any study procedures.\n9. Willing to abstain from donating whole blood or blood derivatives 30 days prior to screening and for the duration of the study.\n10. Willing to refrain from receiving any licensed vaccine within 28 days prior to and after scheduled study injections.\n\nExclusion Criteria:\n\n1. Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Including Acute, subacute, intermittent, or chronic medical diseases or conditions that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the trial. Significant respiratory disease (COPD) requiring daily medications, asthma that is not well controlled, significant cardiovascular disease, history of myocarditis or pericarditis, myocardial infarction, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia, Neurological or neurodevelopmental conditions, ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, blood dyscrasias or significant disorder of coagulation, chronic liver disease, including fatty liver, autoimmune disease, including localized or history of psoriasis or hypothyroidism without a defined non-autoimmune cause and Immunodeficiency of any cause.\n2. Abnormal screening electrocardiogram (ECG)\n3. History of hypersensitivity or severe reactions to previous vaccinations\n4. History of hypersensitivity or severe reactions to products known to contain polyethylene glycol (PEG).\n5. Allergy to antibiotics structurally similar to kanamycin (including but not limited to neomycin, streptomycin, tobramycin, and gentamycin).\n6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunemodifying drugs within 6 months prior to the first study injection (for corticosteroids: prednisone ≥20 mg\u002Fday or equivalent). Intra-articular, inhaled, nasal, and topical steroids are allowed.\n7. Received immunoglobulins or any blood products within 60 days prior to enrollment\u002FDay 1.\n8. Donated blood products within 30 days prior to enrollment\u002FDay 1.\n9. Received an investigational or non-registered medicinal product within 30 days prior to screening.\n10. Currently enrolled, or plan to participate, in another clinical trial with an investigational agent to be received during the study period.\n11. Received or plans to receive any non-study vaccine within 28 days before and after each study injection.\n12. Febrile illness\\*, as determined by the participating site PI or appropriate sub-investigator, with or without fever (oral temperature ≥38.0°C\u002F100.4°F), within 24 hours prior to each study injection.\n13. Current heavy smoking\u002Fvaping (defined as 1 pack or more of cigarettes a day or vaping equivalent\\*). \\*1-2 mL of 20 mg\u002FmL of nicotine salt\n14. Known or suspected alcohol or illicit drug abuse within the past 12 months prior to Study Day 1.\n15. Breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last study injection.\n16. Participants unlikely to cooperate with the requirements of the study protocol.",true,"64 Years",{"count":56,"type":21},48,[58],"PHASE1","The goal of this clinical trial is to assess the safety, tolerability and immunogenicity of three dosage levels, and a single or two-dose administration regimen, of the investigational HDT-321 product administered intra-muscularly. The main questions it aims to answer are:\n\n* Is HDT-321 safe to use\n* Does HDT-321 provide protection against Crimean-Congo hemorrhagic fever virus (CCHFV)\n\nResearchers will record any adverse events and test blood samples to see if HDT-321 is safe and works to protect participants against Crimean-Congo hemorrhagic fever virus (CCHFV)\n\nParticipants will:\n\n* Receive 1 or 2 doses of HDT-321\n* Complete a memory aid and measurements for 7 days after receiving each dose of HDT-321\n* Be followed throughout the study using phone calls and clinic visits to check for and record adverse events\n* Provide blood samples at specific study visits",[61,27],"Vaccine",[61,63,64,65,66,67],"Healthy","18-64","Male","Female","Preventative","2025-07-23",{"date":70,"type":37},"2025-07-28",{"date":72,"type":37},"2025-07-10",{"date":74,"type":21},"2027-07",{"name":76,"class":77},"HDT Bio","INDUSTRY",1]