A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
January 29, 2009 updated by: Chugai Pharmaceutical
A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cancer patients
Exclusion Criteria:
- a history of myocardial, cerebral or pulmonary infarction
- severe hypertension beyond control by drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
patient whose ΔHb is less than 1.0g/dL on the day of 7th administration
|
3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
36000IU(s.c.)/week for 12 weeks
|
|
Experimental: 2
patient whose ΔHb is 1.0g/dL or above on the day of 7th administration
|
3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
36000IU(s.c.)/week for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The increase in Hb concentration
Time Frame: Day 28th or later
|
Day 28th or later
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in QOL scores
Time Frame: 84 days
|
84 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yoshiharu Ishikura, Chugai Pharmaceutical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
February 2, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPO308JP
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.