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Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 4, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chugai Pharmaceutical
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.

Condition Intervention Phase
Anemia Drug: epoetin beta Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Change in Hb [ Time Frame: 16 weeks ]
  • Change in FACT- total Fatigue Subscale score (FSS) [ Time Frame: 16 weeks ]
  • Requirement for RBC transfusion [ Time Frame: 16 weeks ]

Estimated Enrollment: 160
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPOCH Drug: epoetin beta
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
Placebo Comparator: placebo Drug: placebo
Subcutaneous administration of placebo once-weekly for 12 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628043

Chubu Region
Chubu, Japan
Chugoku/Shikoku Region
Chugoku/Shikoku, Japan
Hokkaido/Tohoku Region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu Region
Kanto/Koshinetsu, Japan
Kinki/Hokuriku Region
Kinki/Hokuriku, Japan
Kyushu Region
Kyushu, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Study Chair: Yoshito Suzuki Chugai Pharmaceutical
  More Information

Responsible Party: Chugai Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00628043     History of Changes
Other Study ID Numbers: EPO316 JP
First Submitted: February 24, 2008
First Posted: March 4, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Chugai Pharmaceutical:

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa