Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317902
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-04-21
Brief Title:
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT Epoetin Alfa Dosing 40000-60000 Units On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients CHAMPS II
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT Epoetin Alfa Dosing 40000-60000 Units On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2010-04
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 objective of this study was to treat anemic Hemoglobin Hb 12 gdL HIV-infected subjects with once weekly QW PROCRIT Epoetin alfa to a target Hb of 13 gdL and then to assess if the target Hb level and improvements in Quality of Life QOL could be maintained with every other week Q2W PROCRIT Epoetin alfa dosing
Detailed Description:
This was a Phase IV open-label non-randomized multi-center study conducted in community based practices physicians networks or academic institutions in the US This study included anemic Hb 12 gdL HIV-infected subjects and HIVhepatitis C HCV co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy ART regimen for at least 4 weeks prior to enrollment
Quality of life assessments laboratory results and transfusion information were obtained during the study Laboratory tests vital signs blood pressure and incidence and severity of adverse events were collected and assessed
The primary objective of this study was to assess if every other week PROCRIT Epoetin alfa dosing can maintain quality of life in anemic HIV-infected patients The primary hypothesis of interest was that the mean quality of life score as measured by MOS-HIV General Health Perception score at the end of the every other week Q2W maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points
It was anticipated that less frequent dosing every other week was more convenient for patients and will improve patient compliance The starting dose BaselineStudy Day 1 of PROCRIT Epoetin alfa for all eligible subjects was 40000 U given subcutaneously QW The maximum duration was 24 weeks Subjects who achieved target Hb levels 13 gdL were converted to a maintenance dose of PROCRIT Epoetin alfa sc Q2W
Quality of life assessments laboratory results and transfusion information were obtained during the study Laboratory tests vital signs blood pressure and incidence and severity of adverse events were collected and assessed
The primary objective of this study was to assess if every other week PROCRIT Epoetin alfa dosing can maintain quality of life in anemic HIV-infected patients The primary hypothesis of interest was that the mean quality of life score as measured by MOS-HIV General Health Perception score at the end of the every other week Q2W maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points
It was anticipated that less frequent dosing every other week was more convenient for patients and will improve patient compliance The starting dose BaselineStudy Day 1 of PROCRIT Epoetin alfa for all eligible subjects was 40000 U given subcutaneously QW The maximum duration was 24 weeks Subjects who achieved target Hb levels 13 gdL were converted to a maintenance dose of PROCRIT Epoetin alfa sc Q2W
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