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

October 10, 2013 updated by: Soligenix

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Control
Drug: Placebo
Two tablets QID for 50 days
Experimental: orBec®
Investigational drug
Drug: oral beclomethasone 17,21-dipropionate
Two tablets QID for 50 days
Other Names:
  • BDP
  • orBec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects With GVHD Treatment Failure
Time Frame: Day 80
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 Outcome Measures

Outcome Measure
Time Frame
Cumulative Exposure to Prednisone
Time Frame: Day 80
Day 80
Survival Status
Time Frame: Day 200
Day 200

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soligenix

Investigators

  • Principal Investigator: Keith Sullivan, MD, Duke University
  • Principal Investigator: David Hockenbery, MD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDP-GVHD-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Gastrointestinal Graft vs Host Disease

Clinical Trials on oral beclomethasone 17,21-dipropionate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe