GVHD-budesonide trial

Phase II study to efficacy of budesonide for the treatment of intestinal acute graft-versus-host disease in allogeneic hematopoietic stem cell transplant recipients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs021210039

Enrollment

Registered

2021-09-29

Start date

2021-09-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal acute GVHD

Interventions

Stage 1 of intestinal acute GVHD: Budesonide 9 mg once daily after breakfast + prednisolone 1 mg/kg daily in 2 divided doses. Stage 2-4 of intestinal acute GVHD: Budesonide 9 mg once daily after brea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Intestinal acute GVHD (2) Untreated (3) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 to 2 (4) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Post-treatment for GVHD (2) Skin GVHD stage 3 or higher, liver GVHD stage 1 or higher. (3) Active infection (4) Intestinal disease due to other causes (e.g. CMV enteritis, thrombotic microangiopathy)

Design outcomes

Primary

Measure	Time frame
Overall response rate after 28 days of treatment	—

Secondary

Measure	Time frame
adverse events, reduction rate of systemic steroids, incidence and exacerbation rates of acute GVHD in non-intestinal tracts	—

Contacts

Public ContactTakaya Yamashita

Akita University Hospital

takayay@med.akita-u.ac.jp+81-18-884-6116

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026