The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation

The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation - The safety, efficacy and the predictive factors of efficacy of BDP for acute GVHD

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007439

Enrollment

Registered

2012-03-05

Start date

2012-03-07

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

Hematologic disorders gastrointestinal acute GVHD

Interventions

BDP treatment for gastrointestinal acute GVHD. Both plain gelatin and enteric-coated gelatin capsule of hospital preparation are manufactured by filling 1mg BDP in the pharmaceutical department of our

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with biopsy-proven or clinically strongly suspected gastrointestinal acute GVHD and with symptoms (including nausea or vomiting without >=500ml of diarrhea/day) and with inadequate oral intake (<70% of daily caloric requirements)

Exclusion criteria

Exclusion criteria: 1. Patients requiring systemic steroid treatment for grade 2 acute GVHD of skin and/or liver 2. Patients who cannot intake oral BDP 3. Uncontrollable infection in the gastrointestinal tract 4. Pregnant or possibility pregnant woman 5. Inappropriate to participate in this study as judged by the physician in charge

Design outcomes

Primary

Measure	Time frame
The complete response rate of gastrointestinal acute GVHD at day28 after starting treatment	—

Countries

Japan

Contacts

Public ContactMitsutaka Nishimoto

Graduate School of Medicine, Osaka City University Hematology

nishimo@med.osaka-cu.ac.jp06-6645-3881

Outcome results

None listed

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