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

Soligenix

Status and phase

Terminated

Phase 2

Conditions

Chronic Gastrointestinal Graft vs Host Disease

Treatments

Drug: orBec

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01925950

BDP-GVHD-08

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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