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NCT07135973
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Conditions: Chronic Graft Versus Host Disease
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 26
Sponsor: Sanofi
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 duration will be up to 12 months per participant.
* The treatment duration will be up to 24 weeks.
* The number of visits will be 7.
Eligibility Criteria
Inclusion Criteria:
* 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 \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
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Source: ClinicalTrials.gov (NCT07135973). StuddyBuddy aggregates publicly available trial information.