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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00926575
Recruitment Status : Terminated (An independent Data Safety Monitoring Board recommended the study be stopped due to futility)
First Posted : June 23, 2009
Results First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Soligenix

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Gastrointestinal Graft vs Host Disease
Interventions Drug: oral beclomethasone 17,21-dipropionate
Drug: Placebo
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Placebo
Hide Arm/Group Description oral beclomethasone 17,21-dipropionate (BDP) [Not Specified]
Period Title: Overall Study
Started 70 70
Completed 54 53
Not Completed 16 17
Reason Not Completed
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
Arm/Group Title Active Placebo Total
Hide Arm/Group Description oral beclomethasone 17,21-dipropionate (BDP) [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
  88.6%
66
  94.3%
128
  91.4%
>=65 years
8
  11.4%
4
   5.7%
12
   8.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
34
  48.6%
36
  51.4%
70
  50.0%
Male
36
  51.4%
34
  48.6%
70
  50.0%
1.Primary Outcome
Title The Proportion of Subjects With GVHD Treatment Failure
Hide Description 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
Time Frame Day 80
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to futility
Arm/Group Title Active Placebo
Hide Arm/Group Description:
oral beclomethasone 17,21-dipropionate (BDP)
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Cumulative Exposure to Prednisone
Hide Description [Not Specified]
Time Frame Day 80
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:
oral beclomethasone 17,21-dipropionate (BDP)
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Survival Status
Hide Description [Not Specified]
Time Frame Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:
oral beclomethasone 17,21-dipropionate (BDP)
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 1 to Day 80
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Placebo
Hide Arm/Group Description oral beclomethasone 17,21-dipropionate (BDP) [Not Specified]
All-Cause Mortality
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   32/70 (45.71%)   28/70 (40.00%) 
Blood and lymphatic system disorders     
Acute myeloid leukemia progression  1  0/70 (0.00%)  1/70 (1.43%) 
Angiopathic Anemia  1  0/70 (0.00%)  1/70 (1.43%) 
Leukemic Relapse  1  0/70 (0.00%)  1/70 (1.43%) 
Multiple myeloma progression  1  1/70 (1.43%)  0/70 (0.00%) 
Recurrent AML  1  1/70 (1.43%)  0/70 (0.00%) 
Relapsed ALL  1  0/70 (0.00%)  1/70 (1.43%) 
Relapsed AML  1  0/70 (0.00%)  1/70 (1.43%) 
Thrombotic Thrombocytopenic purpura  1  0/70 (0.00%)  1/70 (1.43%) 
Cardiac disorders     
Atrial fibrillation  1  0/70 (0.00%)  1/70 (1.43%) 
Endocrine disorders     
Diabetic Ketoacidosis  1  1/70 (1.43%)  0/70 (0.00%) 
Gastrointestinal disorders     
Abdominal Cramps  1  1/70 (1.43%)  0/70 (0.00%) 
Ascites  1  1/70 (1.43%)  0/70 (0.00%) 
Diarrhea  1  4/70 (5.71%)  2/70 (2.86%) 
Increased Abdominal Cramping  1  0/70 (0.00%)  1/70 (1.43%) 
Intermittent Diarrhea  1  0/70 (0.00%)  1/70 (1.43%) 
Intractable Nausea  1  0/70 (0.00%)  1/70 (1.43%) 
Intractable vomiting  1  0/70 (0.00%)  1/70 (1.43%) 
Loose Stool  1  0/70 (0.00%)  1/70 (1.43%) 
Nausea  1  2/70 (2.86%)  1/70 (1.43%) 
Obstruction gastric  1  0/70 (0.00%)  1/70 (1.43%) 
Peritoneal Perforation  1  1/70 (1.43%)  0/70 (0.00%) 
Vomiting  1  2/70 (2.86%)  1/70 (1.43%) 
Watery Diarrhea  1  1/70 (1.43%)  0/70 (0.00%) 
General disorders     
Disease Progression  1  1/70 (1.43%)  1/70 (1.43%) 
Drug Withdrawal Syndrome  1  0/70 (0.00%)  1/70 (1.43%) 
DVT  1  1/70 (1.43%)  0/70 (0.00%) 
Fatigue  1  0/70 (0.00%)  1/70 (1.43%) 
Fever  1  2/70 (2.86%)  1/70 (1.43%) 
Flank Pain  1  0/70 (0.00%)  1/70 (1.43%) 
Multi-organ failure  1  1/70 (1.43%)  0/70 (0.00%) 
Progressive disease  1  0/70 (0.00%)  1/70 (1.43%) 
Immune system disorders     
Acute GVHD flare  1  1/70 (1.43%)  0/70 (0.00%) 
Lower GI GVHD  1  0/70 (0.00%)  1/70 (1.43%) 
Infections and infestations     
Back Pain  1  0/70 (0.00%)  1/70 (1.43%) 
Bacteraemia  1  1/70 (1.43%)  1/70 (1.43%) 
BK Viruria  1  1/70 (1.43%)  0/70 (0.00%) 
BK Virus Cystitis  1  0/70 (0.00%)  1/70 (1.43%) 
BK Virus Infection  1  1/70 (1.43%)  0/70 (0.00%) 
Bronchiolitis  1  0/70 (0.00%)  1/70 (1.43%) 
Clostridium difficile infection  1  1/70 (1.43%)  0/70 (0.00%) 
CMV infection  1  2/70 (2.86%)  0/70 (0.00%) 
CMV infection/reactivation  1  1/70 (1.43%)  0/70 (0.00%) 
CMV Pneumonitis  1  1/70 (1.43%)  0/70 (0.00%) 
CMV reaction  1  1/70 (1.43%)  0/70 (0.00%) 
CMV Reactivation  1  0/70 (0.00%)  1/70 (1.43%) 
Gram Negative Bacilli Hyperbilirubinemia  1  1/70 (1.43%)  0/70 (0.00%) 
Gram Negative Bacteremia  1  1/70 (1.43%)  0/70 (0.00%) 
Gram Positive Bacteremia  1  1/70 (1.43%)  0/70 (0.00%) 
Lower Extremities Cellulitis  1  0/70 (0.00%)  1/70 (1.43%) 
Nocardia sepsis  1  0/70 (0.00%)  1/70 (1.43%) 
Pneumonia  1  1/70 (1.43%)  1/70 (1.43%) 
Pneumonia fungal  1  1/70 (1.43%)  0/70 (0.00%) 
Progressive multifocal leukoencephalopathy  1  1/70 (1.43%)  0/70 (0.00%) 
Right orbital cellulitis  1  1/70 (1.43%)  0/70 (0.00%) 
Rotavirus infection  1  1/70 (1.43%)  0/70 (0.00%) 
Sepsis  1  1/70 (1.43%)  0/70 (0.00%) 
Septic Pneumonia  1  0/70 (0.00%)  1/70 (1.43%) 
Septic Shock  1  1/70 (1.43%)  0/70 (0.00%) 
Skin GVHD  1  1/70 (1.43%)  0/70 (0.00%) 
Staph Bacteremia  1  1/70 (1.43%)  0/70 (0.00%) 
Viral Respiratory-type Infection  1  1/70 (1.43%)  0/70 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/70 (0.00%)  1/70 (1.43%) 
Investigations     
RSV Positive  1  0/70 (0.00%)  1/70 (1.43%) 
Metabolism and nutrition disorders     
Dehydration  1  0/70 (0.00%)  1/70 (1.43%) 
Malnutrition  1  0/70 (0.00%)  1/70 (1.43%) 
Poor PO Intake  1  0/70 (0.00%)  1/70 (1.43%) 
Hyperglycaemia  1  2/70 (2.86%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/70 (0.00%)  1/70 (1.43%) 
Weakness  1  0/70 (0.00%)  1/70 (1.43%) 
Pain: Bone Diffuse  1  1/70 (1.43%)  0/70 (0.00%) 
Nervous system disorders     
Dizziness  1  0/70 (0.00%)  1/70 (1.43%) 
Headache  1  0/70 (0.00%)  1/70 (1.43%) 
Meningismus  1  0/70 (0.00%)  1/70 (1.43%) 
Seizure  1  0/70 (0.00%)  1/70 (1.43%) 
Psychiatric disorders     
Mental Status Changes  1  1/70 (1.43%)  0/70 (0.00%) 
Renal and urinary disorders     
Acute Renal Failure  1  1/70 (1.43%)  0/70 (0.00%) 
Renal failure  1  2/70 (2.86%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress with Respiratory Failure  1  0/70 (0.00%)  1/70 (1.43%) 
Hypoxia  1  0/70 (0.00%)  1/70 (1.43%) 
Pleural effusion  1  1/70 (1.43%)  0/70 (0.00%) 
Respiratory distress  1  1/70 (1.43%)  0/70 (0.00%) 
Tachyarrhythmia absoluta  1  0/70 (0.00%)  1/70 (1.43%) 
Vascular disorders     
Hypertension Worsened  1  0/70 (0.00%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.43%
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   70/70 (100.00%)   70/70 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  5/70 (7.14%)  4/70 (5.71%) 
Neutropenia  1  7/70 (10.00%)  7/70 (10.00%) 
Trombocytopenia  1  9/70 (12.86%)  6/70 (8.57%) 
Cardiac disorders     
Tachycardia  1  4/70 (5.71%)  6/70 (8.57%) 
Endocrine disorders     
Adrenal insufficiency  1  4/70 (5.71%)  3/70 (4.29%) 
Eye disorders     
Dry Eye  1  7/70 (10.00%)  1/70 (1.43%) 
Vision Blurred  1  5/70 (7.14%)  4/70 (5.71%) 
Gastrointestinal disorders     
Abdominal distension  1  1/70 (1.43%)  4/70 (5.71%) 
Abdominal pain  1  20/70 (28.57%)  14/70 (20.00%) 
Abdominal pain upper  1  2/70 (2.86%)  3/70 (4.29%) 
Constipation  1  5/70 (7.14%)  4/70 (5.71%) 
Diarrhoea  1  33/70 (47.14%)  17/70 (24.29%) 
Dry Mouth  1  9/70 (12.86%)  8/70 (11.43%) 
Dyspepsia  1  5/70 (7.14%)  3/70 (4.29%) 
Flatulence  1  5/70 (7.14%)  3/70 (4.29%) 
Nausea  1  22/70 (31.43%)  21/70 (30.00%) 
Retching  1  3/70 (4.29%)  0/70 (0.00%) 
Vomiting  1  12/70 (17.14%)  17/70 (24.29%) 
Pyrexia  1  12/70 (17.14%)  9/70 (12.86%) 
General disorders     
Asthenia  1  7/70 (10.00%)  6/70 (8.57%) 
Early Satiety  1  4/70 (5.71%)  1/70 (1.43%) 
Chills  1  2/70 (2.86%)  3/70 (4.29%) 
Fatigue  1  17/70 (24.29%)  22/70 (31.43%) 
Oedema  1  3/70 (4.29%)  2/70 (2.86%) 
Oedema Peripheral  1  6/70 (8.57%)  8/70 (11.43%) 
Immune system disorders     
Acute graft versus host disease in skin  1  5/70 (7.14%)  5/70 (7.14%) 
Hypogammagluobulinaemia  1  6/70 (8.57%)  3/70 (4.29%) 
Infections and infestations     
Bacteraemia  1  6/70 (8.57%)  1/70 (1.43%) 
BK virus infection  1  5/70 (7.14%)  2/70 (2.86%) 
Clostridial infection  1  4/70 (5.71%)  0/70 (0.00%) 
Cytomegalovirus infection  1  15/70 (21.43%)  11/70 (15.71%) 
Cytomegalovirus viraemia  1  5/70 (7.14%)  4/70 (5.71%) 
Epstein- Barr virus infection  1  4/70 (5.71%)  1/70 (1.43%) 
Staphylococcal infection  1  1/70 (1.43%)  3/70 (4.29%) 
Upper respiratory tract infection  1  2/70 (2.86%)  3/70 (4.29%) 
Investigations     
Blood Creatinine increased  1  5/70 (7.14%)  5/70 (7.14%) 
Breath sounds abnormal  1  3/70 (4.29%)  1/70 (1.43%) 
Hepatic enzyme increased  1  3/70 (4.29%)  0/70 (0.00%) 
Blood lactate dehyrogenase increase  1  1/70 (1.43%)  3/70 (4.29%) 
Neutrophil count increased  1  0/70 (0.00%)  3/70 (4.29%) 
Protein total decreased  1  1/70 (1.43%)  3/70 (4.29%) 
Transaminases increased  1  2/70 (2.86%)  4/70 (5.71%) 
Weight decreased  1  8/70 (11.43%)  5/70 (7.14%) 
Metabolism and nutrition disorders     
Anorexia  1  7/70 (10.00%)  3/70 (4.29%) 
Cushingoid  1  5/70 (7.14%)  3/70 (4.29%) 
Decreased appetite  1  16/70 (22.86%)  13/70 (18.57%) 
Dehydration  1  3/70 (4.29%)  3/70 (4.29%) 
Fluid retension  1  3/70 (4.29%)  0/70 (0.00%) 
Fluid overload  1  0/70 (0.00%)  5/70 (7.14%) 
Hyperglycaemia  1  11/70 (15.71%)  12/70 (17.14%) 
Hyperkalaemia  1  9/70 (12.86%)  9/70 (12.86%) 
Hypoalbuminaemia  1  2/70 (2.86%)  3/70 (4.29%) 
Hypocalcaemia  1  1/70 (1.43%)  3/70 (4.29%) 
Hypokalaemia  1  8/70 (11.43%)  9/70 (12.86%) 
Hypomagnesaemia  1  6/70 (8.57%)  4/70 (5.71%) 
Hyponatraemia  1  5/70 (7.14%)  4/70 (5.71%) 
Hypophosphataemia  1  3/70 (4.29%)  4/70 (5.71%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/70 (5.71%)  4/70 (5.71%) 
back pain  1  3/70 (4.29%)  5/70 (7.14%) 
Muscular weakness  1  3/70 (4.29%)  6/70 (8.57%) 
Myalgia  1  4/70 (5.71%)  5/70 (7.14%) 
Pain in extremity  1  4/70 (5.71%)  3/70 (4.29%) 
Nervous system disorders     
Dizziness  1  3/70 (4.29%)  3/70 (4.29%) 
Dysgeusia  1  3/70 (4.29%)  0/70 (0.00%) 
Headache  1  9/70 (12.86%)  9/70 (12.86%) 
Neuropathy peripheral  1  2/70 (2.86%)  4/70 (5.71%) 
Tremor  1  7/70 (10.00%)  8/70 (11.43%) 
Psychiatric disorders     
Anxiety  1  4/70 (5.71%)  3/70 (4.29%) 
Depression  1  7/70 (10.00%)  3/70 (4.29%) 
Insomnia  1  9/70 (12.86%)  9/70 (12.86%) 
Renal and urinary disorders     
Dysuria  1  3/70 (4.29%)  5/70 (7.14%) 
Haematuria  1  3/70 (4.29%)  0/70 (0.00%) 
Pollakiuria  1  3/70 (4.29%)  1/70 (1.43%) 
Renal failure  1  8/70 (11.43%)  6/70 (8.57%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/70 (5.71%)  12/70 (17.14%) 
Dyspnoea  1  3/70 (4.29%)  5/70 (7.14%) 
Dyspnoea exertional  1  5/70 (7.14%)  5/70 (7.14%) 
Rales  1  0/70 (0.00%)  3/70 (4.29%) 
Epstaxis  1  3/70 (4.29%)  2/70 (2.86%) 
Nasal congestion  1  4/70 (5.71%)  2/70 (2.86%) 
Wheezing  1  3/70 (4.29%)  2/70 (2.86%) 
Rhinorrhoea  1  1/70 (1.43%)  7/70 (10.00%) 
Sinus congestion  1  1/70 (1.43%)  3/70 (4.29%) 
Skin and subcutaneous tissue disorders     
Dry Skin  1  6/70 (8.57%)  0/70 (0.00%) 
Ecchymosis  1  4/70 (5.71%)  0/70 (0.00%) 
Erythema  1  4/70 (5.71%)  8/70 (11.43%) 
Pruritus  1  5/70 (7.14%)  5/70 (7.14%) 
Rash  1  9/70 (12.86%)  10/70 (14.29%) 
Rash Macular  1  2/70 (2.86%)  3/70 (4.29%) 
Vascular disorders     
Deep vein thrombosis  1  3/70 (4.29%)  1/70 (1.43%) 
Hypertension  1  19/70 (27.14%)  7/70 (10.00%) 
Hypotension  1  3/70 (4.29%)  4/70 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dhara Patel, Clinical Coordinator
Organization: Soligenix, Inc.
Phone: 609-538-8200
EMail: dpatel@soligenix.com
Layout table for additonal information
Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT00926575     History of Changes
Other Study ID Numbers: BDP-GVHD-03
First Submitted: June 19, 2009
First Posted: June 23, 2009
Results First Submitted: July 12, 2013
Results First Posted: December 6, 2013
Last Update Posted: December 6, 2013