Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210834
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
An Efficacy and Safety Study of Epoetin Alfa PROCRIT Initiated at 40000 Units Every Week Versus 80000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open-Label Study Of Epoetin Alfa PROCRIT Initiated At 40000 Units Every Week Versus 80000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy
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 primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40000 units administered subcutaneously once every week and at 80000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy The secondary objectives of the study are to assess the Hb response time to Hb response transfusion requirements and safety
Detailed Description:
This is a randomized open-label multi-center study to compare end of study hemoglobin level between Epoetin alfa PROCRIT at 40000 units administered subcutaneously once every week qw and at 80000 units subcutaneously every two weeks q2w in approximately 280 anemic patients with cancer receiving chemotherapy The study hypothesis is that a dosing regimen of PROCRIT 80000 Units q2w subcutaneously sc is non-inferior to a dosing regimen of PROCRIT 40000 Units qw sc with respect to the change in hemoglobin Hb from baseline to Study Week 13 for patients with chemotherapy associated anemia and this respective dosing regimen is generally well-tolerated The patients will receive subcutaneous under the skin injections of Epoetin alfa PROCRIT at one of the following dosing regimens 1- Starting dose of 40000 units sc qw once every week OR 2- Starting dose of 80000 units sc q2w every two weeks
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