Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210587
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
An Efficacy and Safety Study for Epoetin Alfa PROCRIT in Cancer Patients Not Receiving Chemotherapy or Radiation
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Pilot Study to Evaluate the Response Rate of Epoetin Alfa PROCRIT at 80000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 epoetin alfa PROCRITÂ administered 80000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy
Detailed Description:
The current approved dosage for epoetin alfa is 40000 Units once per week with an escalation to 60000 Units once per week if the response is inadequate after four weeks of treatment at 40000 Units This dosing scheme while proven to be efficacious is often inconvenient for both patients and medical personnel This is an open-label non-randomized multi-center pilot study with the objective to investigate the efficacy of epoetin alfa PROCRIT with regard to hematopoietic response when administered at 80000 Units subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy or radiation therapy Patients will receive two epoetin alfa injections 40000 Units per injection under the skin once every three weeks for a maximum of 13 weeks totalling a maximum of four treatments 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