Trial of budesonide for acute intestinal GVHD after transplantation

JRCT ID: jRCTs031200450

Registered date:30/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute intestinal GVHD
• Date of first enrollment: 15/09/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Budesonide(9mg/day) added to Prednisolone 1 mg/kg for 100 days, and then after the dose was tapered to 6 mg/day and to 3 mg/day weekly this treatment was finished.The symptom of GVHD is observed, and the dose of prednisolone is adjusted.

Outcome(s)

• Primary Outcome: The proportion of patients requiring second-line therapy for progression of intestinal GVHD within 2 weeks after initial treatment with prednisolone 1 mg/kg plus budesonide for intestinal GVHD

Secondary Outcome

Non-relapse mortality on day 100 (NRM)
Total dose of prednisolone in combination with butesonide
Number of diarrhea surveyed by interview on Days 14 and 28, 42, 70,100,142

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients aged 20 years or older and diagnosed with Stage2 or higher acute intestinal GVHD after allogeneic hematopoietic stem cell transplantation
Patients who can cooperate with questioning and physical examination
Patients with consent to participate in this study

Exclude criteria

Patients with other known abdominal conditions, such as cytomegalovirus infection or TMA
Patients who have difficulty taking stable medications
Patients who are currently receiving oral steroid therapy for other medical conditions
HBsAg-positive patients
Patients with HIV antibody
Patients with uncontrolled psychiatric symptoms
Patients with uncontrolled active infections
Patients with abscesses, intestinal perforations, or active anal fistulas
Patients with a history of intestinal surgery within the past 3 months
Patients with intestinal obstruction, or corresponding symptoms
Patients considered inappropriate by the physician

Related Information

• Primary Sponsor: Hagihara Maki