Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216541
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy
Sponsor:
Janssen-Cilag BV
Organization:
Janssen-Cilag BV
Study Overview
Official Title:
Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care
Detailed Description:
Cancer patients often experience anemia due to the disease itself chemotherapy or both Quality of life is also affected due in part to the tiredness associated with anemia Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention This is a randomized open-label explorative sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer During their current course of chemotherapy patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa epoetin alfa administered when hemoglobin is 10 gdL in addition to best standard care Best standard care during chemotherapy may include red blood cell transfusions white cell growth factors folic acid and iron supplementation as needed Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks 8 or 9 weeks and 12 weeks and at the end of the treatment period Safety evaluations incidence of adverse events abnormal clinical laboratory tests and vital signs will be performed throughout the study The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated Epoetin alfa injections 40000 units under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is 10 gdL Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks Dose may be adjusted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None