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| ID | Type | Description | Link |
|---|---|---|---|
| LTTO; | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | |
| Long Term Treatment Outcomes; | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | |
| PR04-15-001 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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| Name | Class |
|---|---|
| Ortho Biotech Products, L.P. | INDUSTRY |
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The purpose of this trial is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.
The overall study design is based on the assumption that the maximum increase in red blood cells and their effect often does not occur while a subject is in the ICU and acutely ill. The study hypothesis is that a higher hemoglobin (red blood cells) carries more oxygen and delivers oxygen to the tissues. This should increase the ability of the injured subject to tolerate the physical exertion involved in the recuperative process and thus recover earlier than someone with a lower hemoglobin.
One milliliter of a colorless liquid is injected under the subjects skin weekly during their hospital stay and weekly for up to an additional 12 weeks after hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROCRIT | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROCRIT | Drug | 40,000 IU/mL/week for max of 12 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 PF Score | Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100. | Hospital Discharge to Post-Hospital Discharge Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Usual Activity (RTUA) | Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized. | Hospital Discharge to Post-Hospital Discharge Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy McGowan | Janssen Services, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
ITT subjects were all randomized subjects. Three subjects were randomized prior to screening and failed screening. These 3 subjects did not receive any study medication or procedure prior to discontinuation and are not included in the 192 subjects that started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PROCRIT | 40,000 IU/mL/week for maximum of 12 weeks |
| FG001 | Placebo | Placebo given at equivalent volume (1 mL) as Procrit |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
40,000 IU/mL/week for max of 12 weeks |
|
| Orange |
| California |
| United States |
| Santa Barbara | California | United States |
| Denver | Colorado | United States |
| Gainesville | Florida | United States |
| Hollywood | Florida | United States |
| Miami | Florida | United States |
| Maywood | Illinois | United States |
| Springfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Baltimore | Maryland | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Cincinnati | Ohio | United States |
| Dayton | Ohio | United States |
| Allentown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| El Paso | Texas | United States |
| Norfolk | Virginia | United States |
| Morgantown | West Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PROCRIT | 40,000 IU/mL/week for maximum of 12 weeks |
| BG001 | Placebo | Placebo given at equivalent volume (1 mL) as Procrit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | SF-36 PF Score | Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100. | ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge. | Posted | Mean | Standard Deviation | Units on a scale. | Hospital Discharge to Post-Hospital Discharge Week 24 |
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| Secondary | Return to Usual Activity (RTUA) | Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized. | Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge. | Posted | Number | Participants | Hospital Discharge to Post-Hospital Discharge Week 24 |
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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 | PROCRIT | 40,000 IU/mL/week for maximum of 12 weeks | 17 | 96 | 83 | 96 | ||
| EG001 | Placebo | Placebo given at equivalent volume (1 mL) as Procrit | 20 | 92 | 81 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| Peritoneal Haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Wound Necrosis | General disorders | MedDRA 8.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Abdominal Sepsis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Lung Infection Pseudomonal | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Wound Infection Staphylococcal | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Infected Skin Ulcer | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Lobar Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Septic Shock | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Wound Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Haemothorax | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Implant Tissue Necrosis | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Anemia Postoperative | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Fracture Displacement | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Pneumothorax Traumatic | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Post-Traumatic Pain | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Aseptic necrosis Bone | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Fracture Nonunion | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Cerebellar Haematona | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Laryngeal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Deep Vein thrombosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Odema Peripheral | General disorders | MedDRA 8.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
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The study was stopped early due to slow enrollment. Four subjects were randomized but withdrew prior to hospital entry and no data were collected
All information which is supplied by COBS to the investigator & not previously published & any data generated as a result of the study are confidential & remain the sole property of COBS. Investigator will not use the information for other purposes without COBS prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Centocor Ortho Biotech Services, LLC (COBS) | 215-325-4464 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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|