Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Chronic Gastrointestinal Graft vs Host Disease
In brief
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Key facts
- Study ID
- NCT01925950
- Run by
- Soligenix
- People needed
- 2
- Starts
- 2013-12-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2018-11-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
- Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
- Endoscopic findings consistent with GI GVHD
- 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…
- >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
- GI infection
- Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- HIV seropositivity
- Pregnant or nursing female
- Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
- Evidence of recurrent or progressing malignant disorder that was the indication for HCT
Where it is running
- John Theurer Cancer Center — Hackensack, New Jersey, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.