Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350090
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2006-07-07
Brief Title:
A Study to Assess the Response Rate of PROCRIT Epoetin Alfa Given at a Dose of 40000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
A Pilot Study to Evaluate the Response Rate of PROCRIT Epoetin Alfa at 40000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped early due to slow enrollment
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 effectiveness and safety of PROCRIT Epoetin alfa administered at 40000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy
Detailed Description:
This is an open-label both the researcher and the patient in the study know the treatment that is being given non-randomized multi-center pilot study with the objective to investigate the efficacy of PROCRIT Epoetin alfa with regard to hematopoietic response when administered at 40000 Units subcutaneously under the skin once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy Hematological laboratory tests hemoglobin and hematocrit vital signs blood pressure and occurrence and severity of adverse events will be assessed throughout the study Patients will receive a PROCRIT Epoetin alfa injection 40000 Units per injection under the skin once every week for a maximum of 13 weeks Doses may be reduced depending on the patients hemoglobin level
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