Status:
TERMINATED
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Lead Sponsor:
Soligenix
Conditions:
Acute Gastrointestinal Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Significant Skin GVHD
- Liver GVHD
- Persistent vomiting
- HIV positive
- Pregnancy/lactation
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00926575
Start Date
October 1 2009
End Date
May 1 2012
Last Update
December 6 2013
Active Locations (3)
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1
Buffalo, New York, United States
2
Durham, North Carolina, United States
3
Seattle, Washington, United States