[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AiCuris Anti-infective Cures AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100631659","phase-2-a-study-to-understand-how-a-new-unlicensed-drug-aic468-works-compared-with-a-placebo-against-bk-virus-in-patients-who-have-had-a-kidney-transplant-100631659",false,"NCT07503561","A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.","A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2\u002F3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients","Inclusion Criteria:\n\n1. Male or female aged 18 years or older\n2. Kidney transplantation within 12 months prior to randomization\n3. First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:\n\n   1. positive BKV DNA test of one time \\>104 IU\u002FmL and \\\u003C106 IU\u002FmL, within 30 days prior to randomization, or\n   2. \\>103 IU\u002FmL and ≤104 IU\u002FmL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization.\n4. Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \\\u003C1% per year until the end of the trial.\n\n   Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial.\n5. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test prior to randomization on Day 1.\n6. Able and willing to provide written informed consent and comply with trial protocol.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP\n2. Estimated glomerular filtration rate (\\[e\\]GFR) \\\u003C30 mL\u002Fminute\u002F1.73 m2 at screening\n3. Alanine transaminase (ALT) \\>2×upper limit of normal (ULN) or direct bilirubin \\>1.1×ULN (except Gilbert's Disease) at screening\n4. Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period\n5. Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)\n6. Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment.\n7. Participants who received antibody-depletion therapy within 3 months prior to randomization, or in the opinion of the Investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)\n8. Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \\[FSGS\\], C3 glomerulopathy)\n9. Participants with known donor-specific antibodies (\\[DSA\\], de novo, or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\\\u003C1,000 mean fluorescence intensity \\[MFI\\]) can be included if no impact on the trial assessments is expected by the discretion of the Investigator.\n10. Pregnant or nursing (lactating) women\n11. Uncontrolled acute or chronic infections such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), or Epstein-Barr virus (EBV)\n12. History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening\n13. Documented evidence of the use of another Investigational Medicinal Product (IMP) within 30 days or 5 half-lives of randomization, or until the expected PD effect has returned to baseline (whichever is longer)\n14. Known current alcoholism or drug addiction\n15. Any other condition or laboratory abnormality, that in the opinion of the Investigator, would interfere with the evaluation of the IMP or interpretation of the participant safety data or trial results.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.\n\nResearchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.",[26],"BK Virus Infection",[28,29,30,31],"BK Virus","BK Viremia in kidney transplant","antisense oligonucleotide","AIC263029","NOT_YET_RECRUITING","2026-05-06",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":20},"2026-06-15",{"date":40,"type":20},"2026-12-31",{"name":42,"class":43},"AiCuris Anti-infective Cures AG","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":59,"locationsCount":4},"100504142","expanded-access-intermediate-size-treatment-protocol-pritelivir-for-immunocompromised-subjects-with-treatment-resistant-herpes-simplex-virus-type-1-or-2-100504142","NCT05844436","Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects with Treatment Resistant Herpes Simplex Virus Type 1 or 2","Main Inclusion Criteria:\n\n1. Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic-cell or solid organ transplantation, and chronic use of immunosupressive treatment) men and women of any ethnic group aged ≥16 years.\n2. ACV-resistant and foscarnet-resistant\u002Fintolerant mucocutaneous HSV infection based on clinical failure (no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high doses of valacyclovir or famciclovir and\u002For foscarnet iv therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic\u002Fphenotypic testing or ACV-resistant and previously treated in PRIOH-1 Part C.\n3. The current lesion(s) should be confirmed to be positive for HSV before the start of treatment. If not tested beforehand, a lesion swab should be taken for PCR or cell culture before starting treatment, but treatment may be started before obtaining results.\n4. Visual confirmation of lesion at start of treatment (including by endoscopy).\n5. Willing to remain abstinent or use highly effective method of contraception.\n6. Negative pregnancy test for females of childbearing potential at Day 1 and every 4 weeks thereafter.\n7. Patient must be willing and able (in the opinion of the physician) to understand the informed consent form.\n8. Patient must give written informed consent.\n\nMain Exclusion Criteria:\n\n1. Eligibility and feasibility for a patient to participate in a currently ongoing clinical trial with pritelivir.\n2. Known intolerance to pritelivir or any of the excipients (microcrystalline cellulose, croscarmellose sodium, mannitol, colloidal anhydrous silica, magnesium stearate, hydroxy propyl methyl cellulose, polyethylene glycol, calcium diphosphate).\n3. Need to use the following medications at any dose: esomeprazole, rabeprazole. Need to use the medications with the following daily dose levels: omeprazole \\> 20 mg\u002Fd, lansoprazole \\> 20 mg\u002Fd or pantoprazole \\> 80 mg\u002Fd.\n4. Baseline safety laboratory abnormalities:\n\n   1. ANC \\\u003C 1000 cells\u002Fmm3\n   2. Platelet count \\\u003C 25,000 cells\u002Fmm3\n   3. Hemoglobin \\\u003C 8.0 g\u002FdL\n   4. AST or ALT \\> 5 x ULN\n   5. Bilirubin \\> 2.5 x ULN\n5. History or current evidence of gastrointestinal malabsorption which, in the opinion of the physician, may affect the extent of absorption of pritelivir.\n6. Hemodialysis for any indication and ESRD (eGFR \\\u003C15 mL\u002Fmin; stage 5 CKD).\n7. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the physician, may affect the patient's safety.\n8. Abnormalities in hematological, clinical chemical or any other laboratory variables regarded as clinically relevant by the physician unless they are due to underlying disease or condition.\n9. Not able to communicate meaningfully with the physician and site staff.\n10. Any other condition which in the opinion of the physician would interfere with successful completion of the treatment.\n11. Pregnant and\u002For breastfeeding women.","16 Years","EXPANDED_ACCESS","AiCuris Anti-infective Cures AG (AiCuris) is developing pritelivir for the oral treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infections in immunocompromised subjects.\n\nThe purpose of the expanded access program (EAP) is to provide pritelivir to immunocompromised subjects with treatment resistant HSV type 1 or 2 who cannot participate in a clinical trial and for whom no approved treatment option is available.\n\nIn view of the available pre-clinical and clinical data for pritelivir in immunocompromised subjects with treatment resistant HSV, the lack of treatment options, and the demand for compassionate use of pritelivir, AiCuris aims to provide access to pritelivir via this expanded access program (intermediate size treatment protocol) in the USA. The patient population is focused on those immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition. This EAP enables pritelivir to be available as a treatment option for immunocompromised subjects with treatment-resistant HSV type 1 or 2, who do not have access to clinical trial options.",[54],"HSV","AVAILABLE","2025-02-06",{"date":58,"type":36},"2025-02-10",{"name":42,"class":43},""]