Study of orBec (Registered Trademark (R)) With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec(R) (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal Graft Versus Host Disease (GVHD)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000593033

Acronym

SUPPORTS

Enrollment

166

Registered

2010-07-22

Start date

2009-10-13

Completion date

Unknown

Last updated

2026-02-04

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

Conditions

None listed

Brief summary

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Interventions

oral beclomethasone 17,21-dipropionate Two pills (1 milligram) four times a day (8 milligrams) for 50 days. Study drug administered in conjunction with standard of care prednisone therapy.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

*Receipt of allogeneic hematopoietic cell transplant *Diagnosis of gastrointestinal graft versus host disease (GVHD) *No gastrointestinal (GI) infection *Must be able to swallow tablets *Must be able to read and understand informed consent *Adequate birth control methods for the duration of the study

Exclusion criteria

*Significant Skin Graft Versus Host Disease *Liver Graft Versus Host Disease *Persistent vomiting *Human Immunodeficiency Virus (HIV) positive *Pregnancy/lactation

Outcome results