Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398749
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2006-11-10
Brief Title:
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 STAR-2
Sponsor:
Janssen-Cilag BV
Organization:
Janssen-Cilag BV
Study Overview
Official Title:
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2
Status:
COMPLETED
Status Verified Date:
2012-11
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 main purpose of this study is to evaluate the safety and efficacy response of epoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer
Detailed Description:
Anemia has been identified as a common complication and a widespread problem in the cancer population Anemia is a condition in which a patient has below normal levels of hemoglobin the substance in red blood cells that carries oxygen to all parts of the body People with severe anemia may experience fatigue and shortness of breath with activity Therefore this condition can have a negative influence on a persons quality of life Epoetin alfa used to treat anemia in cancer patients is a genetically engineered protein that stimulates red blood cell production This study investigates treatment of anemia using epoetin alfa during chemotherapy in adult patients with cancer The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers This is an observational non-randomized prospective comparative parallel-group survey performed in The Netherlands Patients with various severities of disease may enter the survey as soon as their epoetin alfa treatment starts and will be followed until the end of their epoetin alfa treatment Patient data are collected in Case Report Forms CRFs until 4 weeks after the end of treatment with epoetin alfa At the end of treatment completed CRFs will be collected The assessment of effectivenessresponse will be based on the following cancer type and status chemotherapy and other anti-cancer treatment hemoglobin levels use of blood transfusions and serum iron levels and iron supplementation Safety evaluations include the incidence of serious and non-serious adverse events Because the study is observational dosage administration and duration of treatment is at discretion of treating physician
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPOCAN4018 | None | None | None |