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| ID | Type | Description | Link |
|---|---|---|---|
| EPOANE3018 |
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The study was stopped due to low subject enrollment. No safety issue or other concern factored into this decision.
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| Name | Class |
|---|---|
| Centocor Ortho Biotech Services, L.L.C. | INDUSTRY |
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The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a group of disorders characterized by progressive bone marrow failure and an increased risk of development of leukemia.
This is a randomized (patients are assigned by chance to a treatment group), double-blind (neither the patient or the physician know which treatment is being received by the patient), placebo-controlled, multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria. Patients meeting entry criteria for the study will be randomly assigned to receive epoetin alfa 40,000 IU or 80,000 IU or a matching volume of placebo administered by subcutaneous (under the skin) injection once every week. Doses of study drug will be withheld, decreased, or increased on the basis of weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines. An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression, an independent central reviewer will review bone marrow specimens and peripheral blood counts. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events. Patients in the Treatment Phase will be randomly assigned to receive once weekly epoetin alfa subcutaneously (SC) at a dose of 40,000 IU (1 mL) or 80,000 IU (2ML) or matching volume of placebo (1 mL or 2 mL) once every week for 48 weeks. Patients may continue to receive double-blinded treatment after 48-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks |
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| 002 | Experimental | Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks |
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| 003 | Placebo Comparator | Placebo Matching volume 1 mL for 48 weeks |
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| 004 | Placebo Comparator | Placebo Matching volume 2 mLfor 48 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching volume 2 mLfor 48 weeks |
| |
| Epoetin alfa |
| Measure | Description | Time Frame |
|---|---|---|
| Red Blood Cell (RBC) Transfusion | Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study) | Approximately 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RBC Transfusion From Day 29 Through the End of Study | incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks). | Day 29 through the end of study (approximately 48 weeks) |
| Transfusion Dependent |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | (1ml or 2 mL) subcutaneously once every week |
| FG001 | Epoetin Alfa 40000 IU | (1 mL) subcutaneously once every week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks |
|
| Placebo | Drug | Matching volume 1 mL for 48 weeks |
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| Epoetin alfa | Drug | 80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks |
|
Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period. |
| Approximately 48 weeks |
| FG002 | Epoetin Alfa 80000 IU | (2 mL) subcutaneously once every week |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | (1ml or 2 mL) subcutaneously once every week |
| BG001 | Epoetin Alfa 40000 IU | (1 mL) subcutaneously once every week |
| BG002 | Epoetin Alfa 80000 IU | (2 mL) subcutaneously once every week |
| BG003 | 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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| Region of Enrollment | 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 | Red Blood Cell (RBC) Transfusion | Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study) | The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment. | Posted | Number | participants | Approximately 48 weeks |
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| Secondary | RBC Transfusion From Day 29 Through the End of Study | incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks). | The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment. | Posted | Number | participants | Day 29 through the end of study (approximately 48 weeks) |
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| |||||||||||||||||||||||||||||||||
| Secondary | Transfusion Dependent | Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period. | The intent-to-treat (ITT) population. | Posted | Number | participants | Approximately 48 weeks |
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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 | Placebo | (1ml or 2 mL) subcutaneously once every week | 2 | 8 | 7 | 8 | ||
| EG001 | Epoetin Alfa 40000 IU | (1 mL) subcutaneously once every week | 2 | 8 | 4 | 8 | ||
| EG002 | Epoetin Alfa 80000 IU | (2 mL) subcutaneously once every week | 4 | 9 | 6 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aplasia Pure Red Cell | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Splenomegaly | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 'MedDRA 12.1' | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Asthenia | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | 'MedDRA 12.1' | Non-systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | 'MedDRA 12.1' | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | 'MedDRA 12.1' | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Oral Pain | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Fatigue | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Asthenia | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Hyperthermia | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Pyrexia | General disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Productive Cough | Respiratory, thoracic and mediastinal disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | 'MedDRA 12.1' | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | 'MedDRA 12.1' | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | 'MedDRA 12.1' | Non-systematic Assessment |
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| Blood Urine Present | Investigations | 'MedDRA 12.1' | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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| Hypertension | Vascular disorders | 'MedDRA 12.1' | Non-systematic Assessment |
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Because this study was terminated prematurely due to slow enrollment, only limited data were collected. No formal statistical testing was performed. Only descriptive statistics were provided.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Head of Hematology and Nephrology | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | pbowers@its.jnj.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| ITALY |
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| RUSSIA |
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| USA |
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