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

Phase 3TerminatedNCT00926575

Soligenix140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Acute Gastrointestinal Graft vs Host Disease

Interventions

oral beclomethasone 17,21-dipropionateDRUG

Two tablets QID for 50 days

PlaceboDRUG

Two tablets QID for 50 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Receipt of allogeneic hematopoietic cell transplant * Diagnosis of GI graft vs. host disease (GVHD) * No GI infection * 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: * Significant Skin GVHD * Liver GVHD * Persistent vomiting * HIV positive * Pregnancy/lactation

Locations (3)

Unnamed facility

Buffalo, New York, United States

Unnamed facility

Durham, North Carolina, United States

Unnamed facility

Seattle, Washington, United States

Outcomes

Primary Outcomes

The Proportion of Subjects With GVHD Treatment Failure

The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD

Time frame: Day 80

Secondary Outcomes

Cumulative Exposure to Prednisone

Time frame: Day 80

Survival Status

Time frame: Day 200

Data from ClinicalTrials.gov

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