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
Results First Received: July 12, 2013  
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
Condition: Acute Gastrointestinal Graft vs Host Disease
Interventions: Drug: oral beclomethasone 17,21-dipropionate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active oral beclomethasone 17,21-dipropionate (BDP)
Placebo No text entered.

Participant Flow:   Overall Study
    Active     Placebo  
STARTED     70     70  
COMPLETED     54     53  
NOT COMPLETED     16     17  
Adverse Event                 1                 1  
Death                 4                 4  
Lost to Follow-up                 1                 1  
Physician Decision                 1                 2  
Protocol Violation                 1                 0  
Withdrawal by Subject                 8                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Active oral beclomethasone 17,21-dipropionate (BDP)
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Active     Placebo     Total  
Number of Participants  
[units: participants]
  70     70     140  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     62     66     128  
>=65 years     8     4     12  
Gender  
[units: participants]
     
Female     34     36     70  
Male     36     34     70  



  Outcome Measures
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1.  Primary:   The Proportion of Subjects With GVHD Treatment Failure   [ Time Frame: Day 80 ]

2.  Secondary:   Cumulative Exposure to Prednisone   [ Time Frame: Day 80 ]

3.  Secondary:   Survival Status   [ Time Frame: Day 200 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dhara Patel, Clinical Coordinator
Organization: Soligenix, Inc.
phone: 609-538-8200
e-mail: dpatel@soligenix.com


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