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| ID | Type | Description | Link |
|---|---|---|---|
| EPOSUR4005 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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The study was stopped due to slow enrollment
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| Name | Class |
|---|---|
| Ortho Biotech Clinical Affairs, L.L.C. | INDUSTRY |
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The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red blood cells) transfusions (from the day of surgery to the day of hospital discharge) in participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is defined as the treatment of participants according to the hospital or institution's policy, but where participants will not receive PROCRIT (Epoetin alfa) or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood cells in the bone marrow).
This is a randomized (the study medication is assigned by chance), parallel-arm (each group of participants will be treated at the same time), open-label (all people know the identity of the intervention), multicenter study. The study consists of screening phase of 21 days, treatment phase of 15 days, follow-up phase of 28 days. Approximately 110 participants undergoing elective major abdominal and/or pelvic surgery will be enrolled. During the Treatment Phase, eligible participants will be randomly assigned (participants are assigned to a treatment group based on chance) in a 1:1 ratio to either PROCRIT (Epoetin alfa) or the Standard of Care (SOC) group that will not receive any erythropoiesis-stimulating agents (ESAs). Participants will undergo surgery during the Treatment Phase. After surgery, all participants will stay in the study for 4 days (or until hospital discharge) and followed for an additional 28 days (Follow-up Phase). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The duration of the study for each participant will be approximately 64 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROCRIT (epoetin alfa) | Experimental | Participants will receive PROCRIT (epoetin alfa). |
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| STANDARD THERAPY | Experimental | Participants will receive standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin alfa | Drug | Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions | Day of surgery until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Change From Baseline to End of Study | End of Study Hemoglobin minus baseline Hemoglobin | Baseline (Day-10) to end of study (Day 32) |
| Number of pRBC Units Transfused During Study | Baseline (Day -10) to end of study (Day 32) |
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Inclusion Criteria: - Scheduled to undergo elective major abdominal and/or pelvic surgery with anticipated significant perioperative ((the time period describing the duration of a participants surgical procedure) blood loss (eg, greater than 500 cc and at increased risk for blood transfusion) - Hemoglobin greater than 10 g/dL and less than or equal to 13 g/dL at screening (Day -13 [13 days prior to surgery] to Day -11) and baseline (Day -10) - Patients with reproductive potential and their partners must practice an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study - Female patients with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of PROCRIT - Adequate renal (kidney) and adequate hepatic (liver) function assessed within the 21-day screening period Exclusion Criteria: - No severe Congestive Heart Failure (New York Heart Association Class IV) - No known severe stable or unstable coronary artery disease, or unstable angina - No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months before study entry (prior superficial thrombophlebitis is not an exclusion criterion) - No history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute coronary syndrome (unstable Angina, myocardial Infarction), or other arterial thrombosis within 6 months before study entry - Not anticipated to donate perioperative autologous blood or receive transfusions within 21 days prior to baseline or to have greater than 6 transfusions perioperatively - No prior treatment with PROCRIT or any erythropoiesis-stimulating agents (ESAs) within the previous month
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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37 participants were enrolled in the study. 18 participants were randomly assigned to the epoetin alfa group and 19 were randomly assigned to the Standard therapy group.
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| ID | Title | Description |
|---|---|---|
| FG000 | PROCRIT (Epoetin Alfa) | Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery |
| FG001 | STANDARD THERAPY |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard of Care | Drug | Participants will receive standard of care based on the Institution's treatment policy. |
|
| Hospital Length of Stay | Surgery to hospital discharge |
Participants received standard of care based on the Institution's treatment policy
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PROCRIT (Epoetin Alfa) | Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery |
| BG001 | STANDARD THERAPY | Participants received standard of care based on the Institution's treatment policy |
| 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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| Race/Ethnicity, Customized | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions | ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size | Posted | Number | participants | Day of surgery until hospital discharge |
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| ||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Change From Baseline to End of Study | End of Study Hemoglobin minus baseline Hemoglobin | All Subjects, No formal analysis was conducted due to early termination and small sample size | Posted | Mean | Standard Deviation | g/dL | Baseline (Day-10) to end of study (Day 32) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of pRBC Units Transfused During Study | ITT, No formal analysis was conducted due to early termination and small sample size | Posted | Mean | Standard Deviation | units | Baseline (Day -10) to end of study (Day 32) |
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| Secondary | Hospital Length of Stay | ITT, No formal analysis was conducted due to early termination and small sample size | Posted | Mean | Standard Deviation | days | Surgery to hospital discharge |
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|
64 days
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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 (Epoetin Alfa) | Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery | 5 | 18 | 18 | 18 | ||
| EG001 | STANDARD THERAPY | Participants received standard of care based on the Institution's treatment policy | 8 | 19 | 13 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Device dislocation | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Anticoagulation drug level below therapurtic | Investigations | Med DRA 9.0 | Systematic Assessment |
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| International normalized ratio increased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypergylcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
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| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Ureteric obstruction | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pancreatic fistula | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Application site infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Platelet count increased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Prothrombin level increased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Renal tubular necrosis | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Wound drainage | Surgical and medical procedures | MedDRA 9.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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No formal analysis was conducted due to early termination.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs COBS | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 215-325-4464 |
| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| D059039 | Standard of Care |
| 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 |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| >=65 years |
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| Male |
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| Other |
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| White |
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