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An independent Data Safety Monitoring Board recommended the study be stopped due to futility
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Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orBec® | Experimental | Investigational drug |
|
| Placebo | Placebo Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral beclomethasone 17,21-dipropionate | Drug | Two tablets QID for 50 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Exposure to Prednisone | Day 80 | |
| Survival Status | Day 200 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keith Sullivan, MD | Duke University | Principal Investigator |
| David Hockenbery, MD | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo | New York | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9649455 | Background | 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. | |
| 17244684 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | oral beclomethasone 17,21-dipropionate (BDP) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active | oral beclomethasone 17,21-dipropionate (BDP) |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Data was not analyzed as the study was terminated due to futility | Posted | Day 80 |
|
Day 1 to Day 80
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | oral beclomethasone 17,21-dipropionate (BDP) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myeloid leukemia progression | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dhara Patel, Clinical Coordinator | Soligenix, Inc. | 609-538-8200 | dpatel@soligenix.com |
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| Placebo | Drug | Two tablets QID for 50 days |
|
| Durham |
| North Carolina |
| United States |
| Seattle | Washington | United States |
| 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. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Cumulative Exposure to Prednisone | Posted | Day 80 |
|
|
| Secondary | Survival Status | Posted | Day 200 |
|
|
| 32 |
| 70 |
| 70 |
| 70 |
| EG001 | Placebo | 28 | 70 | 70 | 70 |
| Angiopathic Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukemic Relapse | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Multiple myeloma progression | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Recurrent AML | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Relapsed ALL | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Relapsed AML | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombotic Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Diabetic Ketoacidosis | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Disease Progression | General disorders | MedDRA | Systematic Assessment |
|
| Drug Withdrawal Syndrome | General disorders | MedDRA | Systematic Assessment |
|
| DVT | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Fever | General disorders | MedDRA | Systematic Assessment |
|
| Flank Pain | General disorders | MedDRA | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
|
| Progressive disease | General disorders | MedDRA | Systematic Assessment |
|
| Abdominal Cramps | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Increased Abdominal Cramping | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intermittent Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intractable Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intractable vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Loose Stool | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Peritoneal Perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Watery Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Acute GVHD flare | Immune system disorders | MedDRA | Systematic Assessment |
|
| Lower GI GVHD | Immune system disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| BK Viruria | Infections and infestations | MedDRA | Systematic Assessment |
|
| BK Virus Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| BK Virus Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| CMV infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| CMV infection/reactivation | Infections and infestations | MedDRA | Systematic Assessment |
|
| CMV Pneumonitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| CMV reaction | Infections and infestations | MedDRA | Systematic Assessment |
|
| CMV Reactivation | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gram Negative Bacilli Hyperbilirubinemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gram Negative Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gram Positive Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower Extremities Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nocardia sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA | Systematic Assessment |
|
| Right orbital cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Skin GVHD | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staph Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral Respiratory-type Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| RSV Positive | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Poor PO Intake | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain: Bone Diffuse | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Meningismus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Acute Respiratory Distress with Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Tachyarrhythmia absoluta | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypertension Worsened | Vascular disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Trombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Early Satiety | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute graft versus host disease in skin | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypogammagluobulinaemia | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| BK virus infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Epstein- Barr virus infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Blood Creatinine increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Blood lactate dehyrogenase increase | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cushingoid | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fluid retension | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epstaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided