Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
- Registration Number
- NCT00628043
- Lead Sponsor
- Chugai Pharmaceutical
- 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 with lung cancer or gynecologic cancer undergoing chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - EPOCH epoetin beta -
- Primary Outcome Measures
Name Time Method The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL 16 weeks
- Secondary Outcome Measures
Name Time Method Change in Hb 16 weeks Change in FACT- total Fatigue Subscale score (FSS) 16 weeks Requirement for RBC transfusion 16 weeks
Trial Locations
- Locations (6)
Chugoku/Shikoku Region
🇯🇵Chugoku/Shikoku, Japan
Chubu Region
🇯🇵Chubu, Japan
Kyushu Region
🇯🇵Kyushu, Japan
Hokkaido/Tohoku Region
🇯🇵Hokkaido/Tohoku, Japan
Kinki/Hokuriku Region
🇯🇵Kinki/Hokuriku, Japan
Kanto/Koshinetsu Region
🇯🇵Kanto/Koshinetsu, Japan