Status:
NOT_YET_RECRUITING
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Lead Sponsor:
Sanofi
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
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. Study details include: * The study d...
Eligibility Criteria
Inclusion
- Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent Participants who had an allogeneic hematopoietic cell transplantation (HCT) Previously received at least 2 prior lines of systemic therapy for cGVHD Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening Had persistent cGVHD manifestations and systemic therapy was indicated Karnofsky (if aged ≥ 16 years)/Lansky (if aged \<16 years) Performance Score of ≥ 60
- Capable of giving signed informed consent as described in the protocol
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Absolute neutrophil count ≤1.5 X 109/L Platelet count ≤ 50 X 109/L Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (\>5 × ULN if due to cGVHD) Total bilirubin ≥ 1.5 X ULN Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3 Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening FEV1 ≤39% or has lung score of 3
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2028
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07135973
Start Date
November 28 2025
End Date
March 17 2028
Last Update
October 30 2025
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