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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Gastrointestinal Graft vs Host Disease

In brief

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

Key facts

Study ID

NCT00926575

Run by

Soligenix

People needed

140

Starts

2009-10-01

Expected to finish

2012-05-01

Last updated by the study team

2013-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receipt of allogeneic hematopoietic cell transplant
• Diagnosis of GI graft vs. host disease (GVHD)
• No 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

You may not qualify if…

• Significant Skin GVHD
• Liver GVHD
• Persistent vomiting
• HIV positive
• Pregnancy/lactation

Where it is running

• Study site — Buffalo, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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