[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649804":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":26,"responsibleParty":33,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":26,"enrollmentInfo":47,"targetDuration":26,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":26},{"fullName":5,"class":6},"Halia Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Ofirnoflast","EXPERIMENTAL","Participants receive ofirnoflast once daily, including the 5 participants enrolled in the Phase A safety lead-in cohort. Treatment continues through the 24-Week Initial Treatment Period and, for participants demonstrating clinical benefit, the Extension Period (up to an additional 24 weeks).",[13],"Drug: Ofirnoflast",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Ofirnoflast","Participants randomized to this arm in Phase B receive ofirnoflast once daily. Treatment continues through the 24-Week Initial Treatment Period and, for participants demonstrating clinical benefit, the Extension Period (up to an additional 24 weeks).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Ofirnoflast","once daily.",[9,15],[25],"HT-6184",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Associate Medical Director","CONTACT","385-355-4315","monitor@haliatx.com",{"type":34,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[36],{"name":37,"class":6},"Parexel","100649804","phase-2-evaluate-ofirnoflast-in-adults-with-very-low--to-intermediate-risk-myelodysplastic-syndromes-requiring-transfusions-100649804",false,"NCT07738510","Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Transfusions","A Phase 2b, Multicenter, Open-label, Randomized, Dose Optimization Study of Ofirnoflast (HT-6184) for the Treatment of Anemia in Adults With Very Low- to Intermediate-Risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions","Inclusion Criteria:\n\n1. At least 18 years of age at the time of signing informed consent.\n2. Capable of giving signed informed consent\n3. Documented diagnosis of very low-, low-, or intermediate-risk MDS\n4. Documented diagnosis of anemia\n5. Relapsed or refractory disease after 1 to 3 prior lines of therapy for lower-risk MDS\n6. Willing to provide a bone marrow aspirate at Screening.\n7. Life expectancy of more than 6 months at screening.\n8. Participants of childbearing potential must have a negative pregnancy test at screening (serum) and Day 1 (urine).\n9. Participants and partners must use contraception consistent with local regulations and protocol-defined criteria during the intervention period and for at least 30 days after the last dose; periodic abstinence and withdrawal are not acceptable methods.\n\nExclusion Criteria:\n\n1. Anemia due to other causes (e.g., iron deficiency).\n2. Known clinically significant anemia due to iron, vitamin B12, or folate deficiency; autoimmune or hereditary hemolytic anemia; or gastrointestinal bleeding.\n3. History of hemoglobinopathies, intrinsic RBC membrane\u002Fenzyme defects, or hemolytic anemia.\n4. Prior history of AML, secondary MDS, or other malignancy (except non-melanoma skin cancer or in situ cervical\u002Fbreast carcinoma) unless disease-free for \\>1 year.\n5. Diagnosis of MPN, CMML, or overlap MDS\u002FMPN per WHO classification.\n6. Any condition or concomitant treatment that may impair absorption of orally administered study intervention.\n7. Uncontrolled infection or severe organ dysfunction.\n8. Concomitant intercurrent illness or condition that, per investigator judgment, would compromise safe participation (e.g., uncontrolled hypertension, uncontrolled seizure, unstable angina, new-onset\u002Fexacerbated cardiac arrhythmia).\n9. Prior treatment with disease-modifying agents (e.g., hypomethylating agents) or immunosuppressive therapy, except prior lenalidomide (permitted).\n10. Treatment with cytotoxic chemotherapy or experimental agents within 4 weeks prior to first dose.\n11. History of stem cell, bone marrow, or solid organ transplant.\n12. Known hypersensitivity to ofirnoflast or its excipients.\n13. Severe renal or hepatic impairment\n14. Inability to swallow tablets.\n15. Participation in another interventional clinical study within 90 days prior to first dose.\n16. QTcF \\>480 ms.\n17. Prior treatment with ofirnoflast.","ALL","18 Years",{"count":48,"type":49},50,"ESTIMATED","INTERVENTIONAL",[52],"PHASE2","The primary objective of this study is to evaluate the efficacy and safety of ofirnoflast administered orally once daily in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who are transfusion-dependent and have failed one to three prior therapies, in order to identify the optimal dose for continuation into a Phase 3 study.\n\nThe secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during the dose-selection phase, and to evaluate hematologic improvement with ofirnoflast treatment.",[55,56],"Myelodysplastic Syndromes","Anemia",[58],"Ofirnoflast, HT-6184, Myelodysplastic syndromes, MDS","NOT_YET_RECRUITING","2026-07-29",{"date":62,"type":63},"2026-07-31","ACTUAL",{"date":65,"type":49},"2026-10",{"date":67,"type":49},"2028-12",{"name":5,"class":6}]