- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495378
RAPID-2. A Study to Evaluate the Effectiveness of Alternate Dosing of PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Patients With Chemotherapy Related Anemia
Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia
Study Overview
Detailed Description
This was a retrospective chart review of patients with chemotherapy related anemia. Two hundred (200) patients with chemotherapy related anemia were to have received PROCRIT (Epoetin alfa) on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, once every 3 weeks, or once every 4 weeks) for at least 6 weeks. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated.Study sites were to record data in a Case Report Form which would then be entered into a database. Data was to be recorded, starting with the PROCRIT (Epoetin alfa) initiation phase (at least 4 weeks duration), and extending through at least 6 weeks of maintenance therapy. A minimum of 20 study sites were to be enrolled in the data collection process.Data obtained was to be analyzed to reflect alternate dosing patterns of PROCRIT (Epoetin alfa) therapy. The frequency and percentage of patients receiving each dosing regimen were to be summarized. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated. If PROCRIT (Epoetin alfa) was discontinued, the time and reason(s) for discontinuation were to be recorded.
Patients were to have received PROCRIT (Epoetin alfa) subcutaneous injection on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, 3 weeks, or 4 weeks) for at least 6 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with chemotherapy related anemia
- Patients with a diagnosis of malignancy
- Patients with initial weekly PROCRIT (Epoetin alfa) therapy for at least 4 weeks
- Patients must have received PROCRIT (Epoetin alfa) maintenance therapy with less frequent dosing (e.g. every 2 weeks, every 3 weeks, every 4 weeks) for at least 6 weeks immediately following once weekly dosing.
Exclusion Criteria:
- No previous diagnosis of hemolytic anemia or myelodysplasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ortho Biotech Products, L.P. Clinical Trial, Ortho Biotech, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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