NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

NCT07135973

Not Yet RecruitingPhase 4

Sponsor: Sanofi

Conditions: Chronic Graft Versus Host Disease

Interventions: Belumosudil

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 overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<16 years) Performance Score of ≥ 60
* Capable of giving signed informed consent as described in the protocol

Exclusion Criteria:

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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.