NCT00926575

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

August 1, 2013

Enrollment Period

2.2 years

First QC Date

June 19, 2009

Results QC Date

July 12, 2013

Last Update Submit

October 10, 2013

Conditions

Acute Gastrointestinal Graft vs Host Disease

Keywords

BDPorBecGVHDbeclomethasone dipropionatebone marrow transplanthematopoietic cell transplantHCTstem cell transplantmarrow transplantSCTbeclomethasone 17,21-dipropionate

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 80

Secondary Outcomes (2)

  • Cumulative Exposure to Prednisone

    Day 80

  • Survival Status

    Day 200

Study Arms (2)

orBec®

EXPERIMENTAL

Investigational drug

Drug: oral beclomethasone 17,21-dipropionate

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo

Interventions

oral beclomethasone 17,21-dipropionateDRUG

Two tablets QID for 50 days

Also known as: orBec, BDP
orBec®
PlaceboDRUG

Two tablets QID for 50 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant Skin GVHD
  • Liver GVHD
  • Persistent vomiting
  • HIV positive
  • Pregnancy/lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Related Publications (2)

  • 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.

    PMID: 9649455BACKGROUND

  • 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.

    PMID: 17244684BACKGROUND

Limitations and Caveats

DSMB terminated study for futility; no safety concerns during analysis of patient population. Overall, 1 SAE considered possibly related to study drug, all others were not related to study drug.

Results Point of Contact

Title
Dhara Patel, Clinical Coordinator
Organization
Soligenix, Inc.
dpatel@soligenix.com
609-538-8200

Study Officials

  • Keith Sullivan, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • David Hockenbery, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 23, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

December 6, 2013

Results First Posted

December 6, 2013

Record last verified: 2013-08

Locations

US(3)