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

This study has been terminated.
(An independent Data Safety Monitoring Board recommended the study be stopped due to futility)
Sponsor:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT00926575
First received: June 19, 2009
Last updated: October 10, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Acute Gastrointestinal Graft vs Host Disease
Drug: oral beclomethasone 17,21-dipropionate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Soligenix:

Primary Outcome Measures:
  • The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Cumulative Exposure to Prednisone [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
  • Survival Status [ Time Frame: Day 200 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: orBec®
Investigational drug
Drug: oral beclomethasone 17,21-dipropionate
Two tablets QID for 50 days
Other Names:
  • orBec
  • BDP
Placebo Comparator: Placebo
Control
Drug: Placebo
Two tablets QID for 50 days
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926575

Locations
United States, New York
Buffalo, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Soligenix
Investigators
Principal Investigator: Keith Sullivan, MD Duke University
Principal Investigator: David Hockenbery, MD Fred Hutchinson Cancer Research Center
  More Information

Publications:
Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT00926575     History of Changes
Other Study ID Numbers: BDP-GVHD-03
Study First Received: June 19, 2009
Results First Received: July 12, 2013
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Soligenix:
BDP
orBec
GVHD
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
HCT
stem cell transplant
marrow transplant
SCT
beclomethasone 17,21-dipropionate

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Beclomethasone
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014