Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EPOCAN4028 |
Not provided
Not provided
Not provided
This study was terminated regarding to slow enrollment.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mahidol University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to erythropoietin treatment in cancer related anemia participants receiving chemotherapy. The entire duration of study will be approximately 1 year. Participants will primarily be evaluated for achieving at least 1 gram per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood its red color) level after receiving erythropoietin treatment based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. Response to erythropoietin treatment will also be predicted using other independent hematological (related to blood) factors like C-reactive protein (CRP - is an acute serum protein released from liver). It is associated with low hemoglobin [substance that carries oxygen and gives blood its red color] or erythropoietin [hormone secreted by kidney that helps in formation of red blood cells in bone marrow] resistance), erythropoietin (EPO), hemoglobin, hematocrit (amount of red blood cells in blood), reticulocyte (immature red blood cells) count, ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is in the blood which is bound to transferrin) and transferring iron binding capacity (TIBC), level. Number of blood transfusions and participants' safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with cancer related anemia | Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin: Observational study | Drug | This is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response to Erythropoietin Treatment | Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed. | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical Trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand | |||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Cancer Related Anemia | Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples will be collected for hematological analysis.
| Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 |
CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed. |
| Baseline |
| Serum Hemoglobin Level | Hemoglobin is defined as a substance that carries oxygen and gives blood its red color. | Baseline, Week 1, Week 2, Week 4 and Week 8 |
| Serum Hematocrit Level | Hematocrit is the amount of red blood cells in the blood. | Baseline, Week 1, Week 2, Week 4 and Week 8 |
| Reticulocyte Count | Reticulocytes are immature red blood cells. | Baseline, Week 1, Week 2, Week 4 and Week 8 |
| Serum Ferritin Level | Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron. | Baseline, Week 1 and Week 2 |
| Serum Iron Level | Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin. | Baseline, Week 1 and Week 2 |
| Transferring Iron Binding Capacity (TIBC) | TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. | Baseline, Week 1 and Week 2 |
| Chiang Mai |
| Thailand |
| Khon Kaen | Thailand |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Number of participants analyzed for this baseline characteristic included all the participants who received erythropoietin treatment and had sufficient data to perform statistical evaluation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Cancer Related Anemia | Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants With Response to Erythropoietin Treatment | Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period. | Posted | Number | Percentage of participants | 8 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed. | Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed. | Posted | Number | Participants | Baseline |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 | CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed. | Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed. | Posted | Number | Participants | Baseline |
|
| |||||||||||||||||||||||||||
| Secondary | Serum Hemoglobin Level | Hemoglobin is defined as a substance that carries oxygen and gives blood its red color. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Gram per deciliter (g per dl) | Baseline, Week 1, Week 2, Week 4 and Week 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Hematocrit Level | Hematocrit is the amount of red blood cells in the blood. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Baseline, Week 1, Week 2, Week 4 and Week 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Reticulocyte Count | Reticulocytes are immature red blood cells. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Nanogram per liter | Baseline, Week 1, Week 2, Week 4 and Week 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Ferritin Level | Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Microgram per liter | Baseline, Week 1 and Week 2 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Iron Level | Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Microgram per deciliter (Mcg per dl) | Baseline, Week 1 and Week 2 |
|
| ||||||||||||||||||||||||||
| Secondary | Transferring Iron Binding Capacity (TIBC) | TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. | Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Mcg per dl | Baseline, Week 1 and Week 2 |
|
|
Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Cancer Related Anemia | Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment. | 4 | 25 | 18 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomitting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Skin rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Palpitation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Janssen Cilag Thailand | +6627927232 |
|
|
|
|
|
|
|
|
|
|