Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soligenix
• Treatments: Beclomethasone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• >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