Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210600
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
Early and Standard Intervention With 120000 Units of PROCRIT Epoetin Alfa Every Three Weeks in Patients Receiving Chemotherapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Assessment of Early and Standard Intervention With PROCRIT Epoetin Alfa 120000 Units Once Every Three Weeks Q3W in Patients With Cancer Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-04
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 safety and efficacy of PROCRIT Epoetin alfa when administered at 120000 Units once every three weeks by comparing early dosing Hb 11gdL-12gdL vs standard dosing Hb 11gdL
Detailed Description:
This is a randomized open-label multi-center study Eligible patients will be identified during the screening phase After randomization the Treatment Phase will start at the Day 1 Week 1 visit The entire study period will be up to 22 weeks with the screening phase lasting up to two weeks treatment for a maximum of 16 weeks and safety follow-up for four weeks The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT Epoetin alfa administered at 120000 units subcutaneously sc once every three weeks q3w in 2 patient groups with cancer and anemia receiving chemotherapy
1 Early Intervention Group PROCRIT Epoetin alfa treatment started at patient hemoglobin Hb 110 gdL to 120 gdL and
2 Standard Intervention Group PROCRIT Epoetin alfa treatment started once patient hemoglobin drops to 11 gdL or has a Hb 110 gdL at study entry
For safety monitoring all patients will be followed for adverse events hemoglobin Hb hematocrit Hct blood chemistries and blood pressure measurements throughout the study All eligible patients with hemoglobin 120 gdL will be randomized to receive Epoetin alfa injections 120000 Units under the skin every 3 weeks for a maximum of 16 treatment weeks Doses may be adjusted depending on the patients hemoglobin levels
1 Early Intervention Group PROCRIT Epoetin alfa treatment started at patient hemoglobin Hb 110 gdL to 120 gdL and
2 Standard Intervention Group PROCRIT Epoetin alfa treatment started once patient hemoglobin drops to 11 gdL or has a Hb 110 gdL at study entry
For safety monitoring all patients will be followed for adverse events hemoglobin Hb hematocrit Hct blood chemistries and blood pressure measurements throughout the study All eligible patients with hemoglobin 120 gdL will be randomized to receive Epoetin alfa injections 120000 Units under the skin every 3 weeks for a maximum of 16 treatment weeks Doses may be adjusted depending on the patients hemoglobin levels
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