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

NCT ID: NCT00926575

Last Updated: 2013-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Gastrointestinal Graft vs Host Disease

Keywords

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BDP orBec GVHD beclomethasone dipropionate bone marrow transplant hematopoietic cell transplant HCT stem cell transplant marrow transplant SCT beclomethasone 17,21-dipropionate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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orBec®

Investigational drug

Group Type EXPERIMENTAL

oral beclomethasone 17,21-dipropionate

Intervention Type DRUG

Two tablets QID for 50 days

Placebo

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two tablets QID for 50 days

Interventions

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oral beclomethasone 17,21-dipropionate

Two tablets QID for 50 days

Intervention Type DRUG

Placebo

Two tablets QID for 50 days

Intervention Type DRUG

Other Intervention Names

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orBec BDP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soligenix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

David Hockenbery, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Buffalo, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

References

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McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35. doi: 10.1016/s0016-5085(98)70361-0.

Reference Type BACKGROUND
PMID: 9649455 (View on PubMed)

Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. doi: 10.1182/blood-2006-05-021139. Epub 2007 Jan 23.

Reference Type BACKGROUND
PMID: 17244684 (View on PubMed)

Other Identifiers

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BDP-GVHD-03

Identifier Type: -

Identifier Source: org_study_id