A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
Phase 3
20 Years
79 Years
20 Years
79 Years
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
Inclusion Criteria:
- Lung cancer or gynecologic cancer patients
- Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin
(EPO) or placebo administration
- 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
- 20 - 79 years old
- Performance status: 0 - 2
- No iron deficiency anemia
Exclusion Criteria:
- Red blood cell transfusion within 4 weeks before treatment
- Erythropoietin therapy within 8 weeks before treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
Outcome Time Frame:
16 weeks
Safety Issue:
Yes
Principal Investigator
Yoshito Suzuki
Investigator Role:
Study Chair
Investigator Affiliation:
Chugai Pharmaceutical
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
EPO316 JP
NCT ID:
NCT00628043
Start Date:
May 2008
Completion Date:
September 2009
Related Keywords:
- Anemia
- Cancer
- patients
- with
- chemotherapy
- induced
- anemia
- Anemia
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