Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
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ClinicalTrials.gov Identifier: NCT01925950
(The study was stopped due to patient enrollment challenges.)
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
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