Status:
COMPLETED
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Anemia
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief Summary
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients wit...
Eligibility Criteria
Inclusion
- Lung cancer or gynecologic cancer patients
- Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
- 0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
- 20 - 79 years old
- Performance status: 0 - 2
- No iron deficiency anemia
Exclusion
- Red blood cell transfusion within 4 weeks before treatment
- Erythropoietin therapy within 8 weeks before treatment
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00628043
Start Date
May 1 2008
End Date
September 1 2009
Last Update
September 18 2009
Active Locations (6)
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1
Chugoku/Shikoku Region
Chugoku/Shikoku, Japan
2
Chubu Region
Chūbu, Japan
3
Hokkaido/Tohoku Region
Hokkaido/Tohoku, Japan
4
Kanto/Koshinetsu Region
Kanto/Koshinetsu, Japan