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Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

NCT00926575 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-12-06

Study results available
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Summary

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

Conditions

  • Acute Gastrointestinal Graft vs Host Disease

Interventions

DRUG

oral beclomethasone 17,21-dipropionate

Two tablets QID for 50 days

DRUG

Placebo

Two tablets QID for 50 days

Sponsors & Collaborators

  • Soligenix

    lead INDUSTRY

Principal Investigators

  • Keith Sullivan, MD · Duke University

  • David Hockenbery, MD · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00926575 on ClinicalTrials.gov