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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144482 |
To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy
Condition | Intervention | Phase |
---|---|---|
Chemotherapy Induced Anemia |
Drug: recombinant human erythropoietin Drug: recombinant human erythropoietin placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy |
Enrollment: | 122 |
Study Start Date: | December 2003 |
Study Completion Date: | August 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: recombinant human erythropoietin
36000IU(0.5mL)s.c./week for 8 weeks
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2: Placebo Comparator |
Drug: recombinant human erythropoietin placebo
0 IU(0.5mL)s.c./week for 8 weeks
|
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | EPO307JP |
Study First Received: | September 2, 2005 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00144482 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Epoetin Alfa Anemia |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |