RecruitingPhase 3ACTRN12610000593033

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)


Sponsor

Soligenix, Inc.

Enrollment

166 participants

Start Date

Oct 13, 2009

Study Type

Interventional

Conditions

Summary

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is studying a drug called orBec alongside standard prednisone treatment for graft-versus-host disease (GVHD) affecting the gut. GVHD happens when immune cells from a donated bone marrow or stem cell transplant attack the recipient's own body. OrBec is a steroid that works locally in the gut with fewer whole-body side effects, which could make treatment safer. You may be eligible if: - You are 18 years of age or older - You have received an allogeneic (donor) stem cell or bone marrow transplant - You have been diagnosed with gastrointestinal GVHD - You do not have a gut infection - You are able to swallow tablets and use adequate birth control You may NOT be eligible if: - You have significant GVHD of the skin or liver - You have persistent vomiting - You are HIV positive - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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.


Locations(1)

United States of America

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ACTRN12610000593033