[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603396":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":31,"collaborators":23,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":23,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":23,"enrollmentInfo":42,"targetDuration":23,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":23,"overallStatus":51,"whyStopped":23,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":23},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"belumosudil","EXPERIMENTAL","200 mg taken orally once daily with food for 24 weeks",[13],"Drug: Belumosudil",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Belumosudil","Pharmaceutical form:Tablet-Route of administration:Oral",[9],[21,22],"SAR445761","Rezurock",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","contact-us@sanofi.com",{"type":32,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100603396","phase-4-a-study-to-investigate-safety-of-belumosudil-in-participants-aged-12-years-and-above-with-chronic-graft-versus-host-disease-cgvhd-100603396",false,"NCT07135973","A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)","A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)","Inclusion Criteria:\n\n* Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent\n* Participants who had an allogeneic hematopoietic cell transplantation (HCT)\n* Previously received at least 2 prior lines of systemic therapy for cGVHD\n* Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening\n* Had persistent cGVHD manifestations and systemic therapy was indicated\n* Karnofsky (if aged ≥ 16 years)\u002FLansky (if aged \\\u003C16 years) Performance Score of ≥ 60\n* Capable of giving signed informed consent as described in the protocol\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Absolute neutrophil count ≤1.5 X 109\u002FL\n* Platelet count ≤ 50 X 109\u002FL\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (\\>5 × ULN if due to cGVHD)\n* Total bilirubin ≥ 1.5 X ULN\n* Glomerular filtration rate (GFR) ≤ 30 mL\u002Fmin\u002F1.73m3\n* Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening\n* FEV1 ≤39% or has lung score of 3\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","12 Years",{"count":43,"type":44},26,"ESTIMATED","INTERVENTIONAL",[47],"PHASE4","This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.\n\nStudy details include:\n\n* The study duration will be up to 12 months per participant.\n* The treatment duration will be up to 24 weeks.\n* The number of visits will be 7.",[50],"Chronic Graft Versus Host Disease","NOT_YET_RECRUITING","2026-05-11",{"date":54,"type":55},"2026-05-12","ACTUAL",{"date":57,"type":44},"2026-08-10",{"date":59,"type":44},"2028-03-17",{"name":5,"class":6}]